Collection Device With Selective Display of Test Results, Method And Computer Program Product Thereof

ABSTRACT

A collection device with a selective display of test results and method thereof are disclosed. A structured collection procedure defining data collection times and the associated context of the collection also defines what information regarding the results of the collection may be viewable by a user performing the structured collection procedure on the device. In this manner, the patient can be monitored according to the structured collection procedure while preventing the patient from modifying his or her behavior based on collection results.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation in part of U.S. patentapplication Ser. No. 12/643,415, filed Dec. 21, 2009, which claimspriority to U.S. Provisional Application Ser. No. 61/140,270 filed Dec.23, 2008, both of which are incorporated by reference herein in theirentirety.

TECHNICAL FIELD

Embodiments of the invention relate generally to meters used forphysiological monitoring, and in particular, to a collection device withselective display of test results, method and computer program productthereof.

BACKGROUND

For people with diabetes, successful management requires monitoring theeffects lifestyle changes can have in both short-term and long-term timeframes. Regular testing of their blood glucose level can be an importantpart of diabetes management as a way to track changes throughout theday. For example, portable handheld medical diagnostic devices are oftenemployed to measure concentrations of biologically significantcomponents of bodily fluids, such as, for example, glucose concentrationin blood. To test glucose with a glucose meter, a small sample of bloodmay be placed on a disposable test strip. The portable handheld glucosemeter may include a strip port that receives the disposable test strip.The test strip may be coated with chemicals (glucose oxidase,dehydrogenase, or hexokinase) that combine with glucose in bloodallowing it to measure the concentration of glucose in the blood sample.The portable handheld glucose meter then displays the glucoseconcentration as a number (or glucose measurement value). As a result,the portable handheld medical diagnostic devices and their accessoriesmay work together to measure the amount of glucose in blood and be usedto monitor glucose levels in one's home, healthcare facility or otherlocation, for example, by persons having diabetes or by a healthcareprofessional.

Patients and healthcare professionals may thereby track and analyzeglucose measurements over a period of time to assess changes in thepatient over the course of a day, week or other desirable timeframe. Inother examples, some healthcare professionals may instruct a patient toobtain glucose measurements several times a day over a course of a fewconsecutive days as part of a test regime or protocol implemented inhopes to observe and assess changes in a patient's physiologicalcondition. For example, the protocol may specify taking blood glucosemeasurements which correlate to certain eating times, meal types andsize, exercising, and so forth.

It is to be appreciated that in conventional glucose meters the resultsof such glucose measurements are readily viewable by the patient as wellas any other data that may be collected by the meter. However, patientsfollowing a certain protocol for testing a physiological parameter likeglucose and optionally collecting additional information as prescribedby the protocol may change intentionally or unintentionally theirbehavior when they see the test results. Since such a protocol may beused to assess a certain aspect of a patient's current medicalsituation, a modification of the patient's behavior while following theprotocol may negatively impact the validity of the test results.

SUMMARY

It is against the above background that the present invention disclosesa method, system, and computer program product for providing a selectivedisplay of test results. Using the embodiments of the present invention,a clinician can monitor a patient according to a desired structuredcollection procedure while preventing the patient from modifying his orher behavior based on the collection results obtained from the patientperforming the collection procedure. For example, if a patient typicallymeasures blood glucose once per day at a specific time and the patient'sclinician wants to gather additional blood glucose readings but does notwant the patient to change his or her eating or other habits based onthe additional test results, the clinician can define a structuredcollection procedure which instructs the patient to test multiple timesper day but only allows the collection device to present a single testresult to the patient corresponding to the patient's normal testingtime. In this manner, the patient will not be able to modify his or hernormal behavior based on the additional test results.

In one embodiment, a portable collection device is disclosed andcomprises a display; a user interface; a measurement engine to measure abiomarker value; memory containing a data file and a structuredcollection procedure. The structured collection procedure has parametersdefining: a schedule of collection events having one or more collectionevents which provide a request for a measurement of the biomarker valueunder defined conditions which are related to the biomarker value ascontextual information associated with the biomarker value, and a viewflag associated with each of the one or more collection events. The viewflag has a viewable value and a non-viewable value. The device furthercomprises a processor is connected to the display, the user interface,the measurement engine, and the memory, a power supply for powering thedevice, and software. The software has instructions that when executedby the processor causes the processor to: read the structured collectionprocedure from memory, permit an authorized user to select at least onecriterion under which a data record of the data file for the structuredcollection procedure is designated as viewable, run the structuredcollection procedure, send automatically the request of each of the oneor more collection events according to the structured collectionprocedure, store automatically biomarker value(s) measured by themeasurement engine or information entered via the user interface in anassociated data record of the data file in the memory in response tosent request, store and link automatically contextual informationassociated with each biomarker value or the information entered in theassociated data record of the data file to form contextualized biomarkerdata, designate automatically the associated data record in the memorycontaining the contextualized biomarker data as viewable if the viewflag associated with the sent request in the structured collectionprocedure has the viewable value or the at least one criterion is metand as not viewable if the view flag has the non-viewable value or theat least one criterion is not met, and provide only biomarker valuesassociated to data records containing the contextualized biomarker dataif the data records are designated in the memory as viewable.

In another embodiment, a method of monitoring a patient according to adesired structured collection procedure while preventing the patientfrom modifying his or her behavior based on collection results isdisclosed. The method comprises providing a portable collection deviceaccording to the above embodiment of the present invention, and runningthe software provided on the collection device. In running the software,the processor: reads the structured collection procedure from memory,runs the structured collection procedure, sends automatically requeststo the display according to the timing of the collection eventsprescribed by the structured collection procedure, stores automaticallyeach biomarker value measured by the measurement engine or informationentered via the user interface in an associated data record of the datafile in the memory in response to the sent requests, stores and linksautomatically contextual information associated with each biomarkervalue or the information entered in the associated data record of thedata file to form contextualized biomarker data, designatesautomatically the associated data record containing the contextualizedbiomarker data in the memory as viewable if the view flag provided inthe structured collection procedure for the collection event has theviewable value and as not viewable if the view flag has the non-viewablevalue, and provides to the display only data records containing thecontextualized biomarker data designated in the memory as viewable.

In still another embodiment, a computer readable storage medium isdisclosed which stores software comprising instructions that whenexecuted by a collection device having a processor, a measurement enginefor measuring a biomarker value, a user interface, memory, and a displayperforms a method for monitoring a patient according to a desiredstructured collection procedure while preventing the patient frommodifying his or her behavior based on collection results. The methodexecuted by the processor comprises: running the structured collectionprocedure; sending automatically requests to the user interfaceaccording to timing of collection events prescribed by the structuredcollection procedure; storing automatically each biomarker valuemeasured by the measurement engine or information entered via the userinterface in an associated data record in a data file provided in thememory in response to the sent requests; storing and linkingautomatically contextual information associated with each biomarkervalue or the information entered in the associated data record of thedata file to form contextualized biomarker data, designatingautomatically the associated data record containing the contextualizedbiomarker data in the memory as viewable if the view flag provided inthe structured collection procedure for the collection event has theviewable value and as not viewable if the view flag has the non-viewablevalue; and providing to the display only data records containing thecontextualized biomarker data designated in the memory as viewable.

These and other advantages, features, and embodiments of the inventiondisclosed herein will be made more apparent from the description,drawings and claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the embodiments of the presentinvention can be best understood when read in conjunction with thefollowing drawings, in which:

FIG. 1 is a diagram showing a chronic care management system for adiabetes patient and a clinician along with others having an interest inthe chronic care management of the patient according to an embodiment ofthe present invention;

FIGS. 2 and 2A are diagrams showing embodiments of a system suitable forimplementing a structured collecting procedure according to anembodiment of the present invention;

FIG. 3 depicts a block diagram conceptually illustrating a portablecollection device useful to implement the various embodiments of thepresent invention;

FIG. 4 shows a depiction in tabular format of a data record embodimentcreated from using a structured collection procedure on the collectiondevice of FIG. 3 according to the present invention;

FIG. 5A depicts a method of creating a structured collection procedurefor a medical use case and/or question according to an embodiment of thepresent invention;

FIGS. 5B and 5C show parameters defining a structured collectionprocedure and factors which can be considered to optimize a patient'stherapy using the structured collection procedure, respectively,according to one or more embodiments of the present invention;

FIGS. 6A, 6B, 6C, 6D, and 6E show various structured collectionprocedures embodiments defined according to the present invention;

FIG. 7A depicts a structured collection procedure for diagnostic ortherapy support of a patient with a chronic disease according to anembodiment of the present invention;

FIG. 7B depicts a structured collection procedure according to anembodiment of the present invention which may be implemented on thecollection device in the embodiment shown by FIG. 3;

FIG. 8A shows a method for performing a structured collection procedureaccording to an embodiment of the present invention;

FIGS. 8B and 8C show a method of implementing a structured collectionprocedure via a graphical user interface provided on a collectiondevice, such as depicted by FIG. 3, according to an embodiment of thepresent invention; and

FIG. 9 depicts a flow diagram depicting a testing method according to anembodiment of the present invention.

DETAILED DESCRIPTION

The present invention will be described below relative to variousillustrative embodiments. Those skilled in the art will appreciate thatthe present invention may be implemented in a number of differentapplications and embodiments and is not specifically limited in itsapplication to the particular embodiments depicted herein. Inparticular, the present invention will be discussed below in connectionwith diabetes management via sampling blood, although those of ordinaryskill will recognize that the present invention could be modified to beused with other types of fluids or analytes besides glucose, and/oruseful in managing other diseases besides diabetes.

As used herein with the various illustrated embodiments described below,the following terms include, but are not limited to, the followingmeanings.

The term “biomarker” can mean a physiological variable measured toprovide data relevant to a patient such as for example, a blood glucosevalue, an interstitial glucose value, an HbA1c value, a heart ratemeasurement, a blood pressure measurement, lipids, triglycerides,cholesterol, and the like.

The term “contextualizing” can mean documenting and interrelatingconditions that exist or will occur surrounding a collection of aspecific biomarker measurement. Preferably, data about documenting andinterrelating conditions that exist or will occur surrounding acollection of a specific biomarker are stored together with thecollected biomarker data and are linked to it. In particular, a furtherassessment of the collected biomarker data takes into account the dataabout documenting and interrelating conditions so that not only the dataas such are evaluated but also the link between data to which it iscontextualized. The data about documenting and interrelating conditionscan include, for example, information about the time, food and/orexercises which occurs surrounding a collection of a specific biomarkermeasurement and/or simultaneously thereto. For example, the context of astructured collection procedure in an embodiment according to thepresent invention can be documented by utilizing entry criterion forverifying a fasting state with the user before accepting a biomarkervalue during a Basal titration optimization structured collectionprocedure.

The term “contextualized biomarker data” can mean the information on theinterrelated conditions in which a specific biomarker measurement wascollected combined with the measured value for the specific biomarker.In particular, the biomarker data are stored together with theinformation on the interrelated conditions under which a specificbiomarker measurement was collected and are linked thereto.

The term “criteria” can mean one criterion or more criteria, and can beat least one or more of a guideline(s), rule(s), characteristic(s), anddimension(s) used to judge whether one or more conditions are satisfiedor met to begin, accept, and/or end one or more procedural steps,actions, and/or values.

The term “adherence” can mean that a person following a structuredcollection procedure performs requested procedural steps appropriately.For example, the biomarker data should be measured under prescribedconditions of the structured collection procedure. If then theprescribed conditions are given for a biomarker measurement theadherence is defined as appropriate. For examples, the prescribedconditions are time related conditions and/or exemplarily can includeeating of meals, taking a fasting sample, eating a type of meal with arequested window of time, taking a fasting sample at a requested time,sleeping a minimum amount of time, and the like. The adherence can bedefined as appropriate or not appropriate for a structured collectionprocedure, a group of sample instances, or a single data point of acontextualized (biomarker) data. Preferably, the adherence can bedefined as appropriate or not appropriate by a range of a prescribedcondition(s) or by a selectively determined prescribed condition(s).Moreover the adherence can be calculated as a rate of adherencedescribing in which extent the adherence is given for a structuredcollection procedure, or a single data point in particular of acontextualized biomarker data.

The term “adherence event” can mean when a person executing a structuredcollection procedure fails to perform a procedural step. For example, ifa person did not collect data when requested by the collection device,the adherence is determined as not appropriate resulting in an adherenceevent. In another example, adherence criteria could be a first criterionfor the patient to fast 6 hours and a second criterion for collecting afasting bG value at a requested time. In this example, if the patientprovides the bG sampling at the requested time but fasted only 3 hoursbefore providing the bG sample, then although the second adherencecriterion is met, the first adherence criterion is not, and hence anadherence event for the first criterion would occur.

The term “violation event” is a form of an adherence event in which theperson executing the structured collection (testing) procedure(protocol) does not administer a therapeutic at a recommended time, doesnot administer a recommended amount, or both.

The term “adherence criterion” can include adherence and can also mean abasis for comparison (e.g., assessment) of a measured value, a valuerelated to a measured value and/or a calculated value with a definedvalue or defined range of the value wherein based on the comparison dataare accepted with approval and positive reception. Adherence criterioncan take into account time related values and/or adherence in oneembodiment, but also can take into account noise in other embodiments,and the like. Furthermore, adherence criterion can be applied tocontextualized biomarker data so that a biomarker data is accepteddepending on a comparison of the contextualized data about documentingand interrelating conditions that exists or occurs surrounding thecollection of the specific biomarker. Adherence criterion can be akin toa sanity check for a given piece of information, or group ofinformation. Preferably, the single data point/information or group ofdata or information is rejected if the accepted criterion is notfulfilled. In particular, such rejected data are then not used forfurther calculations which are used to provide a therapy recommendation.Mainly the rejected data are only used to assess the adherence and/or totrigger automatically at least one further action. For example, such atriggered action prompts the user then to follow a structured collectionprocedure or a single requested action so that based on that theadherence criterion can be fulfilled. The adherence criterion(s)additionally can be used as a trigger or logical switch for a filteringaction, such as, deciding what information can be displayed.

The term “data event request” can mean an inquiry for a collection ofdata at a single point in space-time defined by a special set ofcircumstances, for example, defined by time-related or not time-relatedevents.

The term “medical use case or question” can mean at least one or more ofa procedure, situation, condition, and/or question providing anuncertainty about the factuality, or existence of some medical facts,combined with a concept that is not yet verified but that if true wouldexplain certain facts or phenomena. A medical use case or question canbe pre-loaded in the system so that the user can select betweendifferent medical use cases or questions. Alternatively, the medical usecase or question can be defined by the user themselves.

The terms “focused”, “structured”, and “episodic” are used hereininterchangeably with the term “testing” and can mean a predefinedsequence in which to conduct the testing.

The terms “software” and “program” may be used interchangeably herein.

FIG. 1 shows a chronic care management system 10 for a diabetespatient(s) 12 and a clinician(s) 14 along with others 16 having aninterest in the chronic care management of the patient 12. Patient 12,having dysglycemia, may include persons with a metabolic syndrome,pre-diabetes, type 1 diabetes, type 2 diabetes, and gestationaldiabetes. The others 16 with an interest in the patient's care mayinclude family members, friends, support groups, and religiousorganizations all of which can influence the patient's conformance withtherapy. The patient 12 may have access to a patient computer 18, suchas a home computer, which can connect to a public network 50 (wired orwireless), such as the internet, cellular network, etc., and couple to adongle, docking station, or device reader 22 for communicating with anexternal portable device, such as a portable collection device 24. Anexample of a device reader is shown in the manual “Accu-Chek® Smart PixDevice Reader User's Manual” (2008) available from Roche Diagnostics.

The collection device 24 can be essentially any portable electronicdevice that can function as an acquisition mechanism for determining andstoring digitally a biomarker value(s) according to a structuredcollection procedure, and which can function to run the structuredcollection procedure and the method of the present invention. In apreferred embodiment, the collection device 24 can be a self-monitoringblood glucose meter 26 or a continuous glucose monitor 28. Greaterdetails regarding these various illustrated embodiments of thestructured collection procedure are provided hereafter in latersections.

In addition to the collection device 24, the patient 12 can use avariety of products to manage his or her diabetes including: test strips30 carried in a vial 32 for use in the collection device 24; diabetessoftware 34 which can operate on the patient computer 18, the collectiondevice 24, a handheld computing device 36, such as a laptop computer, apersonal digital assistant, and/or a mobile phone; and paper tools 38.Software 34 can be pre-loaded or provided either via a computer readablemedium 40 or over the public network 50 and loaded for operation on thepatient computer 18, the collection device 24, the cliniciancomputer/office workstation 25, and the handheld computing device 36, ifdesired. In still other embodiments, the software 34 can also beintegrated into the device reader 22 that is coupled to the computer(e.g., computers 18 or 25) for operation thereon, or accessed remotelythrough the public network 50, such as from a server 52.

The patient 12 can also use for certain diabetes therapies additionaltherapy devices 42 and other devices 44. Additionally, therapy devices42 can include devices such as an ambulatory infusion pump 46, aninsulin pen 48, and a lancing device 51. An example of an ambulatoryinsulin pump 46 include but not limited thereto the Accu-Chek® Spiritpump described in the manual “Accu-Chek® Spirit Insulin Pump System PumpUser Guide” (2007) available from Disetronic Medical Systems AG. Theother devices 44 can be medical devices that provide patient data suchas blood pressure, fitness devices that provide patient data such asexercise information, and elder care device that provide notification tocare givers. The other devices 44 can be configured to communicate witheach other according to standards planned by Continua® Health Alliance.

The clinicians 14 for diabetes are diverse and can include e.g., nurses,nurse practitioners, physicians, endocrinologists, and other such healthcare providers. The clinician 14 typically has access to a cliniciancomputer 25, such as a clinician office computer, which can also beprovided with the software 34. A healthcare record system 27, such asMicrosoft® HealthVault™ and Google™ Health, may also be used by thepatient 12 and the clinician 14 on computers 18, 25 to exchangeinformation via the public network 50 or via other network means (LANs,WANs, VPNs, etc.), and to store information such as collection data fromthe collection device 24 to an electronic medical record of the patiente.g., EMR 53 (FIG. 2A) which can be provided to and from computers 18,25 and/or server 52.

Most patients 12 and clinicians 14 can interact over the public network50 with each other and with others having computers/servers 52. Suchothers can include the patient's employer 54, a third party payer 56,such as an insurance company who pays some or all of the patient'shealthcare expenses, a pharmacy 58 that dispenses certain diabeticconsumable items, a hospital 60, a government agency 62, which can alsobe a payer, and companies 64 providing healthcare products and servicesfor detection, prevention, diagnosis and treatment of diseases. Thepatient 12 can also grant permissions to access the patient's electronichealth record to others, such as the employer 54, the payer 56, thepharmacy 58, the hospital 60, and the government agencies 62 via thehealthcare record system 27, which can reside on the clinician computer25 and/or one or more servers 52. Reference hereafter is also made toFIG. 2.

FIG. 2 shows a system embodiment suitable for implementing a structuredtesting method according to an embodiment of the present invention,which in another embodiment can be a part of the chronic care managementsystem 10 and communicate with such components, via conventional wiredor wireless communication means. The system 41 can include the cliniciancomputer 25 that is in communication with a server 52 as well as thecollection device 24. Communications between the clinician computer 25and the server 52 can be facilitated via a communication link to thepublic network 50, to a private network 66, or combinations thereof. Theprivate network 66 can be a local area network or a wide are network(wired or wireless) connecting to the public network 50 via a networkdevice 68 such as a (web) server, router, modem, hub, and the likes.

In one embodiment, the server 52 can be a central repository for aplurality of structured collection procedures (or protocols) 70 a, 70 b,70 c, 70 d, in which the details of a few exemplary structuredcollection procedures are provided in later sections. The server 52, aswell as the network device 68, can function also as a data aggregatorfor completed ones of the structured collection procedures 70 a, 70 b,70 c, 70 d. Accordingly, in such an embodiment, data of a completedcollection procedure(s) from a collection device of the patient 12 canthen be provided from the server 52 and/or network device 68 to theclinician computer 25 when requested in response to a retrieval for suchpatient data.

In one embodiment, one or more of the plurality of structured collectionprocedures 70 a, 70 b, 70 c, 70 d on the server 52 can be provided overthe public network 50, such as through a secure web interface 55 (FIG.2A, showing another embodiment of the system 41) implemented on thepatient computer 18, the clinician computer 25, and/or the collectiondevice 24. In another embodiment, the clinician computer 25 can serve asthe interface (wired or wireless) 72 between the server 52 and thecollection device 24. In still another embodiment, the structuredcollection procedures 70 a, 70 b, 70 c, 70 d, as well as software 34,may be provided on a computer readable medium 40 and loaded directly onthe patient computer 18, the clinician computer 25, and/or thecollection device 24. In still another embodiment, the structuredcollection procedures 70 a, 70 b, 70 c, 70 d may be provided pre-loaded(embedded) in memory of the collection device 24. In still otherembodiments, new/updated/modified structured collection procedures 70 a,70 b, 70 c, 70 d may be sent between the patient computer 18, theclinician computer 25, the server 52 and/or the collection device 24 viathe public network 50, the private network 66, via a direct deviceconnection (wired or wireless) 74, or combinations thereof. Accordingly,in one embodiment the external devices e.g., computers 18 and/or 25, canbe used to establish a communication link 72, 74 between the collectiondevice 24 and still further electronic devices such as other remotePersonal Computer (PC), and/or servers such as through the publicnetwork 50, such as the Internet and/or other communication networks(e.g., LANs, WANs, VPNs, etc.), such as private network 66.

The clinician computer 25, as a conventional personalcomputer/workstation, can include a processor 76 which executesprograms, such as software 34, and such as from memory 78 and/orcomputer readable medium 40. Memory 78 can include system memory (RAM,ROM, EEPROM, etc.), and storage memory, such as hard drives and/or flashmemory (internal or external). The clinician computer 25 can alsoinclude a display driver 80 to interface a display 82 with the processor76, input/output connections 84 for connecting user interface devices86, such as a keyboard and mouse (wired or wireless), and computerreadable drives 88 for portable memory and discs, such as computerreadable medium 40. The clinician computer 25 can further includecommunication interfaces 90 for connections to the public network 50 andother devices, such as collection device 24 (wired or wireless), and abus interface 92 for connecting the above mentioned electroniccomponents to the processor 76. Reference hereafter is now made to FIG.3.

FIG. 3 is a block diagram conceptually illustrating a portablecollection device 24 utilized to implement the present invention suchas, for example, the portable collection device 24 depicted in FIG. 2.It is to be appreciated that the collection device 24 can be essentiallyany portable electronic device that can function as an acquisitionmechanism for determining and storing digitally a biomarker value(s)according to a structured collection procedure, and which can functionto run the structured collection procedure and the method of the presentinvention.

In one embodiment, the collection device 24 is a portable,self-monitoring blood glucose meter (e.g., meter 26) which makes adetermination of a blood glucose level via a measurement instrument thatreads glucose concentrations by optical, electrochemical,electromechanical or calorimetric detection/measurement methods. Anexample of a blood glucose meter is an Accu-Chek® Aviva described in thebooklet “Accu-Chek® Aviva Blood Glucose Meter Owner's Booklet (2007),portions of which are disclosed in U.S. Pat. No. 6,645,368 B1 entitled“Meter and method of using the meter for determining the concentrationof a component of a fluid” assigned to Roche Diagnostics Operations,Inc., which is hereby incorporated by reference.

In another embodiment, the collection device 24 can be a continuousglucose monitor (e.g., monitor 28). As a continuous glucose monitor, thecollection device 24 can be used to obtain time-resolved data toidentify fluctuations and trends that would otherwise go unnoticed withspot monitoring of blood glucose levels and standard HbA1c tests such aslow overnight glucose levels, high blood glucose levels between meals,early morning spikes in blood glucose levels, and how diet and physicalactivity affect blood glucose along with the effect of therapy changes.An example of a continuous glucose monitor is shown in U.S. Pat. No.7,389,133 “Method and device for continuous monitoring of theconcentration of an analyte” (Jun. 17, 2008) assigned to RocheDiagnostics Operations, Inc., which is hereby incorporated by reference.

In the illustrated embodiment of FIG. 3, the collection device 24includes one or more microprocessors, such as processor 102, which maybe a central processing unit comprising a single or multi-core and cachememory, which is connected to a communication bus 104, which may includedata, memory, control and/or address buses. The collection device 24 mayinclude a display interface 106 providing graphics, text, and other datafrom the bus 104 (or from a frame buffer not shown) for display on adisplay 108. The display interface 106 may be a display driver of anintegrated graphics solution that utilizes a portion of main memory 110of the collection device 24, such as random access memory (RAM) andprocessing from the processor 102 or may be a dedicated graphicprocessing unit. In another embodiment, the display interface 106 anddisplay 108 additionally provide a touch screen interface for providingdata to the collection device 24 in a well-known manner.

Main memory 110 in one embodiment is random access memory (RAM), and inother embodiments may include other memory such as a ROM, PROM, EPROM orEEPROM, and combinations thereof. In one embodiment, the collectiondevice 24 can include secondary memory 112 which may include, forexample, a hard disk drive 114 and/or a removable storage drive,representing a floppy disk drive, a magnetic tape drive, an optical diskdrive, a flash memory connector (e.g., USB connector, Firewireconnector, and PC card slot), etc. The removable storage drive 122 readsfrom and/or writes to a removable storage unit 120 in a well-knownmanner. Removable storage unit 120 represents a floppy disk, magnetictape, optical disk, flash drive, PC card, etc., which is read by andwritten to by removable storage drive 122. As will be appreciated, theremovable storage unit 120 includes a computer usable storage mediumhaving stored therein computer software and/or data.

In alternative embodiments, secondary memory 112 may include other meansfor allowing computer programs or other instructions to be loaded intothe collection device 24. Such means may include, for example, theremovable computer readable medium 40 and an interface connector 116.Examples of such a removable computer readable medium/interface includea program cartridge and cartridge interface, a removable memory chip(e.g., ROM, PROM, EPROM, EEPROM, etc.) and associated socket, and otherremovable computer readable medium 40 and interface connector 116 whichallow software and data to be transferred from the removable computerreadable medium 40 to the collection device 24.

The collection device 24 in one embodiment includes a communicationmodule 124. The communication module 124 allows software and data to betransferred between the collection device 24 and an external device(s)132. Examples of communication module 124 may include one or more of amodem, a network interface (such as an Ethernet card), a communicationsport (e.g., USB, firewire, serial, parallel, etc.), a PC or PCMCIA slotand card, a wireless transceiver, and combinations thereof. The externaldevice(s) 132 can be a personal computer (PC), a personal digitalassistance (PDA), a mobile (cellular) phone, and/or a device dockingstation. In such an embodiment, the docking station may provided and/orconnect to one or more of a modem, a network interface (such as anEthernet card), a communications port (e.g., USB, firewire, serial,parallel, etc.), a PCMCIA slot and card, a wireless transceiver, andcombinations thereof. Software and data transferred via communicationmodule 124 are in the form of wired or wireless signals 128 which may beelectronic, electromagnetic, optical, or other signals capable of beingsent and received by communication module 124. For example, as is known,signals 128 may be sent between communication module 124 and theexternal device(s) 132 using wire or cable, fiber optics, a phone line,a cellular phone link, an RF link, an infrared link, othercommunications channels, and combinations thereof.

In one embodiment, the external device 132 is used for establishing acommunication link between the collection device 24 and still furtherelectronic devices such as a remote Personal Computer (PC) of thepatient, e.g., patient computer 18, and/or a health care provider (HCP)computer, e.g., clinician computer 25, directly or indirectly, such asthrough a communication network, such as the public network 50 and/orother communication networks, e.g., private network 66 (e.g., LANs,WANs, VPNs, etc.). The communication module 124 and/or externaldevice(s) 132 may also be used to communicate with further datagathering and/or storage devices such as insulin delivering devices,cellular phones, personal digital assistants (PDA), etc. Specifictechniques for connecting electronic devices through wired and/orwireless connections (e.g. USB and Bluetooth, respectively) are wellknown in the art. In another embodiment, the collection device 24 isused with the external device 132, such as provided as a handheldcomputer or a mobile phone, to perform actions such as prompt a patientto take an action, acquire a data event, and perform calculations oninformation. An example of a collection device combined with such anexternal device 132 provided as a hand held computer is disclosed inU.S. patent application Ser. No. 11/424,757 filed Jun., 16, 2006entitled “System and method for collecting patient information fromwhich diabetes therapy may be determined,” assigned to Roche DiagnosticsOperations, Inc., which is hereby incorporated by reference. Thecollection device 24 may also communicate with other device as discussedpreviously above, which can be medical devices that provide patient datasuch as blood pressure, fitness devices that provide patient data suchas exercise information, and elder care device that provide notificationto care givers.

In the illustrative embodiment, the collection device 24 provides ameasurement engine 138 for reading a biosensor 140. The biosensor 140,which in one embodiment is a disposable test strip (e.g., test strip30), is used with the collection device 24 to receive a sample such asfor example, of capillary blood, which is exposed to an enzymaticreaction and measured by electrochemistry techniques, opticaltechniques, or both by the measurement engine 138 to measure and providea biomarker value, such as for example, a blood glucose level. Anexample of a disposable biosensor and measurement engine is disclosed inU.S. Patent Pub. No. 2005/0016844 A1 entitled “Reagent stripe for teststrip” (Jan. 27, 2005), and assigned to Roche Diagnostics Operations,Inc., which is hereby incorporated by reference. In other embodiments,the measurement engine 138 and biosensor 140 is of a type used toprovide a biomarker value for other types of sampled fluids or analytesbesides or in addition to glucose, heart rate, blood pressuremeasurement, and combinations thereof. In still another embodiment, thebiosensor 140 may be a sensor with an indwelling catheter(s) or being asubcutaneous tissue fluid sampling device(s), such as when thecollection device 24 is implemented as a continuous glucose monitor(CGM) (e.g., monitor 28) in communication with infusion pump 46.

Data, comprising the information provided by the biosensor 140, isprovided by the measurement engine 138 to the processor 102, which mayexecute a computer program stored in memory 110 to perform variouscalculations and processes using the data. For example, such a computerprogram is described by U.S. patent application Ser. No. 12/492,667,filed Jun. 26, 2009, titled “Method, system, and computer programproduct for providing both an estimated true mean blood glucose valueand estimated glycated hemoglobin (HbA1C) value from structured spotmeasurements of blood glucose,” and assigned to Roche DiagnosticsOperations, Inc., which is hereby incorporated by reference. The datafrom the measurement engine 138 and the results of the calculation andprocesses by the processor 102 using the data is herein calledself-monitored data. The self-monitored data may include, but notlimited thereto, the glucose values of a patient 12, the insulin dosevalues, the insulin types, and the parameter values used by processor102 to calculate future glucose values, supplemental insulin doses, andcarbohydrate supplement amounts as well as such values, doses, andamounts. Such data along with a date and time for each measured glucosevalue and administered insulin dose value is stored in a data file 145of memory 110 and/or 112. An included clock 144 of the collection device24 supplies the current date and time to processor 102 for such use.

The collection device 24 further provides a user interface 146 such as,for example, buttons, keys, a trackball, touchpad, touch screen, etc.,for data entry, program control, information requests, and the likes. Inone embodiment, the user interface 146 comprises buttons 147, 149 forentry and navigation of the data provided in memory 110 and/or 112. Inone embodiment, the buttons 147, 149 are used by the patient to enter(document) contextualizing information, such as data related to theeveryday lifestyle of the patient 12 and to acknowledge that prescribedtasks are completed. Such lifestyle data may relate to food intake,medication use, energy levels, exercise, sleep, general healthconditions and overall well-being sense of the patient 12 (e.g., happy,sad, rested, stressed, tired, etc.). Such lifestyle data can be recordedinto memory 110 and/or 112 of the collection device 24 as part of theself-monitored data via navigating through a selection menu displayed ondisplay 108 using buttons 147, 149 and/or via a touch screen userinterface provided by the display 108. It is to be appreciated that theuser interface 146 can also be used to display on the display 108 theself monitored data or portions thereof if made viewable as governed bythe method according to the present invention which is discussedhereafter in later sections.

In one embodiment, the collection device 24 is switched on by pressingany one of the buttons 147, 149. In another embodiment, in which thebiosensor 140 is a test-strip, the collection device 24 is automaticallyswitched on when the test-strip is inserted into the collection device24 for measurement by the measurement engine 138 of a glucose level in asample of blood placed on the test-strip. In one embodiment, thecollection device 24 can be switched off by holding down one of thebuttons 147, 149 for a pre-defined period of time, or in anotherembodiment shut down automatically after a pre-defined period of non-useof the user interface 146.

An indicator 148 is also connected to processor 102, and operates underthe control of processor 102 to emit audible, tactile (vibrations),and/or visual alerts/reminders to the patient of daily times for bGmeasurements and events, such as for example, to take a meal, ofpossible future hypoglycemia, and the likes. A suitable power supply 150is also provided to power the collection device 24 as is well known tomake the device portable.

The software 34 when received by the processor 102 of the collectiondevice 24 is stored in main memory 110 (as illustrated) and/or secondarymemory 112. The software 34 contains instructions, when executed by theprocessor 102, enables the processor to perform the features/functionsof the present invention as discussed herein in later sections. Inanother embodiment, the software 34 may be stored in a computer programproduct and loaded by the processor 102 into cache memory to cause theprocessor 102 to perform the features/functions of the invention asdescribed herein. In another embodiment, the software 34 is implementedprimarily in hardware logic using, for example, hardware components suchas application specific integrated circuits (ASICs). Implementation ofthe hardware state machine to perform the feature/functions describedherein will be apparent to persons skilled in the relevant art(s). Inyet another embodiment, the invention is implemented using a combinationof both hardware and software.

In an example software embodiment of the invention, the methodsdescribed hereafter are implemented in the C++ programming language, butcould be implemented in other programs such as, but not limited to,Visual Basic, C, C#, Java or other programs available to those skilledin the art or alternatively using script language or other proprietaryinterpretable language used in conjunction with an interpreter.Reference hereafter is also made to FIG. 4.

FIG. 4 depicts in tabular form a data file 145 containing data records152 of self-monitored data 154 resulting from a structured collectionprocedure according to an embodiment of the present invention. The datarecords 152 (e.g., rows) along with the self-monitoring data 154 (e.g.,various one of the columns) can also provide associated therewithcontextual information 156 (e.g., other various ones of the columns aswell as via row and column header information). Such contextualinformation 156 can be collected either automatically, such as forexample via input received automatically from the measurement engine,the biosensor, and/or any one of the other devices, or via inputreceived from the user interface which was manually enter by the patientin response to a collection request (e.g., a question displayed by theprocessor 102 on the display 108) during the structured collectionprocedure. Accordingly, as such contextual information 156 can beprovided with each data record 152 in a preferred embodiment, suchinformation is readily available to a clinician and no furthercollection of such information is necessarily needed to be providedagain by the patient either manually or orally after completing thestructured collection procedure. In another embodiment, if suchcontextual information 156 and/or additional contextual information iscollected after completion of a structured collection procedureaccording to the present invention, such information may be provided inthe associated data file and/or data record 145, 152 at a later timesuch as via one of the computers 18, 25. Such information would then beassociated with the self-monitored data in the data file 145, and thuswould not need to be provided again orally or manually. Such a processin the latter embodiment may be needed in the situation where thestructured collection procedure is implemented as or partly as a papertool 38 which is used with a collection device incapable of running thesoftware 34 implementing such a structured collection procedure.

It is to be appreciated that the date file 145 (or portions thereof,such as only the self-monitored data 154) can be sent/downloaded (wiredor wireless) from the collection device 24 via the communication module124 to another electronic device, such the external device 132 (PC, PDA,or cellular telephone), or via the public network 50 to the cliniciancomputer 25. Clinicians can use the diabetes software provided on theclinician computer 25 to evaluate the received self-monitored data 154as well as the contextual information 156 of the patient 12 for therapyresults. An example of some of the functions which may be incorporatedinto the diabetes software and which is configured for a personalcomputer is the Accu-Chek® 360 Diabetes Management System available fromRoche Diagnostics that is disclosed in U.S. patent application Ser. No.11/999,968 filed Dec. 7, 2007, titled “Method and system for settingtime block,” and assigned to Roche Diagnostics Operations, Inc.

In a preferred embodiment, the collection device 24 can be provided asportable blood glucose meter, which is used by the patient 12 forrecording self-monitored data comprising insulin dosage readings andspot measured glucose levels. Examples of such bG meters as mentionedabove previously include but are not limited to, the Accu-Chek® Activemeter and the Accu-Chek® Aviva system both by Roche Diagnostics, Inc.,which are compatible with the Accu-Chek® 360° Diabetes managementsoftware to download test results to a personal computer or theAccu-Chek® Pocket Compass Software for downloading and communicationwith a PDA. Accordingly, it is to be appreciated that the collectiondevice 24 can include the software and hardware necessary to process,analyze and interpret the self monitored data in accordance withpredefined flow sequences (as described below in detail) and generate anappropriate data interpretation output. In one embodiment, the resultsof the data analysis and interpretation performed upon the storedpatient data by the collection device 24, and if such stored patientdata is designated as viewable as described hereafter in later sections,can be displayed in the form of a report, trend-monitoring graphs, andcharts to help patients manage their physiological condition and supportpatient-doctor communications. In other embodiments, the bG data fromthe collection device 24, again if designated as viewable, may be usedto generated reports (hardcopy or electronic) via the external device132 and/or the patient computer 18 and/or the clinician computer 25.

The collection device 24 in other embodiments can further provide thepatient 12, with at least one or more of the capabilities comprising: a)editing data descriptions, e.g., the title and description of a record;b) saving records at a specified location, in particular inuser-definable directories as described above; c) recalling viewablerecords for display; d) searching viewable records according todifferent criteria (date, time, title, description etc.); e) sortingviewable records according to different criteria (e.g., values of the bGlevel, date, time, duration, title, description, etc.); and ifpermitted, f) deleting records; g) exporting records; and/or h)performing data comparisons, modifying records, and excluding records asis well known.

As used herein, lifestyle can be described in general as a pattern in anindividual's habits such as meals, exercise, and work schedule. Theindividual additionally may be on medications such as insulin therapy ororals that they are required to take in a periodic fashion. Influence ofsuch action on glucose is implicitly considered by the presentinvention.

It is to be appreciated that the processor 102 of the collection device24 can implement one or more structured collection procedures 70provided in memory 110 and/or 112. Each structured collection procedure70 in one embodiment can be stand-alone software, thereby providing thenecessary program instructions which when executed by the processor 102causes the processor to perform the structured collection procedure 70as well as other prescribed functions. In other embodiments, eachstructured collection procedure 70 can be part of the software 34, andcan be then be selectively executed by the processor 102 either viareceiving a selection from a menu list provided in the display 108 fromthe user interface 146 in one embodiment or via activation of aparticular user interface, such as a structured collection procedure runmode button (not shown) provided to the collection device 24 in anotherembodiment. It is to be appreciated that the software 34, likewise,provides the necessary program instructions which when executed by theprocessor 102 causes the processor to perform the structured collectionprocedure 70 as well as other prescribed functions of the software 34discussed herein. One suitable example of having a selectable structuredcollection procedure provided as a selectable mode of a collection meteris disclosed by in U.S. patent application Ser. No. 12/491,523, filedJun. 25, 2009, titled “Episodic blood glucose monitoring system with aninteractive graphical user interface and methods thereof,” assigned toRoche Diagnostics Operations, Inc.

In still another embodiment, a command instruction can be sent from theclinician computer 25 and received by the processor 102 via thecommunication module 124, which places the collection device 24 in acollection mode which runs automatically the structured collectionprocedure 70. Such a command instruction may specify which of the one ormore structured collection procedures to run and/or provide a structuredcollection procedure to run. In still another embodiment, a list ofdefined medical use cases or medical questions can be presented on thedisplay 108 by the processor 102, and a particular structured collectionprocedure 70 can be automatically chosen by the processor 102 from aplurality of structured collection procedures (e.g., procedures 70 a, 70b, 70 c, and 70 d) depending on the selection of the defined medical usecases or medical questions received by the processor 102 via the userinterface 146.

In still another embodiment, after selection, the structured collectionprocedure(s) 70 can be provided through the computer readable medium 40and loaded by the collection device 24, downloaded from computers 18and/or 25, the other device(s) 132, or server 52. Server 52, forexample, may be a healthcare provider or company providing suchpre-defined structured collection procedures 70 for downloadingaccording to a selected defined medical use case or question. It is tobe appreciated that the structured collection procedure(s) 70 may bedeveloped by a healthcare company (e.g. company 64) and implemented viathe public network 50 through a webpage and/or made available fordownloading on server 52, such as illustrated in FIG. 2. In still otherembodiments, notices that a new structured collection procedure 70 isavailable for use on the collection device 24 to help address aparticular use case/medical question that a user (e.g., healthcareprovider and patient) may have can be provided in any standard fashion,such for via postal letters/cards, email, text messaging, tweets, andthe likes.

In some embodiments, as mentioned above previously, a paper tool 38 canperform some of the functions provided by the diabetes software 34. Anexample of some of the functions which may be incorporated into thediabetes software 34 and which is configured as a paper tool 38 is theAccu-Chek® 360 View Blood Glucose Analysis System paper form availablefrom Roche Diagnostics also disclosed in U.S. patent application Ser.No. 12/040,458 filed Feb. 29, 2007 entitled “Device and method forassessing blood glucose control,” assigned to Roche DiagnosticOperations, Inc.

In still another embodiment, the software 34 can be implemented on thecontinuous glucose monitor 28 (FIG. 1). In this manner, the continuousglucose monitor 28 can be used to obtain time-resolved data. Suchtime-resolved data can be useful to identify fluctuations and trendsthat would otherwise go unnoticed with spot monitoring of blood glucoselevels and standard HbA1c tests. Such as, for example, low overnightglucose levels, high blood glucose levels between meals, and earlymorning spikes in blood glucose levels as well as how diet and physicalactivity affect blood glucose along with the effect of therapy changes.

In addition to collection device 24 and software 34, clinicians 14 canprescribe other diabetes therapy devices for patients 12 such as anambulatory insulin pump 46 as well as electronically based insulin pen48 (FIG. 1). The insulin pump 46 typically includes configurationsoftware such as that disclosed in the manual “Accu-Chek® Insulin PumpConfiguration Software” also available from Disetronic Medical SystemsAG. The insulin pump 46 can record and provide insulin dosage and otherinformation, as well as the electronically based insulin pen 48, to acomputer, and thus can be used as another means for providing biomarkerdata as requested by the structured collection procedure 70 (FIG. 2)according to the present invention.

It is to be appreciated that, and as mentioned above previously, one ormore of the method steps discussed hereafter can be configured as apaper tool 38 (FIG. 1), but preferably all the method steps arefacilitated electronically on system 41 (FIG. 2) or on any electronicdevice/computer, such as collection device 24, having a processor andmemory as a program(s) residing in memory. As is known, when a computerexecutes the program, instructions codes of the program cause theprocessor of the computer to perform the method steps associatedtherewith. In still other embodiments, some or all of the method stepsdiscussed hereafter can be configured on computer readable medium 40storing instruction codes of a program that, when executed by acomputer, cause the processor of the computer to perform the methodsteps associated therewith. These method steps are now discussed ingreater detail hereafter with reference made to FIGS. 5A and 5B.

Create a Structured Collection Procedure

FIG. 5A depicts a method 200 of creating a structured collectionprocedure 70 illustrated by FIG. 5B for a medical use case or questionwhich may be implemented in any one of the above described devices 18,24, 25, 26, 28, 36, 52 as stand alone software, as part of the diabetessoftware 34 or portions there of as part of paper tool 38. In step 202,a medical use case or question, hereafter referred to generally as usecase(s), is selected and/or can be defined. It is to be appreciated thatuse cases may be, for example, questions concerning finding a diagnosis,how best to initialize therapy for a patient, finding a determination ofstatus of a patient disease progression, finding the best ways tooptimize a patient therapy, and the like. Still other examples can beproviding such structured collection procedures 70 which can be used tohelp address medical questions regarding fasting blood glucose,pre-prandial glucose values, postprandial glucose values, and the like.Other medical questions can be to control the biomarker in a predefinedcontext, to optimize the biomarker in a predefined context, related totherapy onset, type of therapy, oral mono-therapy, oral combinationtherapy, insulin therapy, lifestyle therapy, adherence to therapy,therapy efficacy, insulin injection or inhalation, type of insulin,split of insulin in basal and bolus, and the likes. For example, medicalquestions regarding oral mono-therapy and oral combination could includethose involving sulfonylureas, biguanides, thiazolidinediones,alpha-glucosidase inhibitors, meglitinides, dipeptidyl peptidase IVinhibitors, GLP-1 analogs, taspoglutide, PPAR dual alpha/gamma agonists,aleglitazar. The selected use case can be assigned to a medical use caseparameter 220 depicted in FIG. 5B.

In step 204, the situation or problem surrounding the selected use casecan be defined. This can be accomplished via looking at all the factorswhich may affect a change in the use case. For example, in the use caseof desiring to know how best to optimize a patient's therapy somefactors to look at may include stress, menstrual cycle, pre-dawn effect,background insulin, exercise, bolus timing with respect to a meal, basalrate, insulin sensitivity, post-prandial behavior, and the like such asshown by FIG. 5C.

In step 206, a determination can be made as to what kinds of analysiscan be used to address or shed light on the situation or the problem.Such analysis may be, for example, selected from the following:evaluating the change in fasting blood glucose (FPG) values over thecourse of the structured collection procedure 70, monitoring one or moreparticular value over the duration of the structured collectionprocedure 70, determining an insulin to carbohydrate (I:C) ratio,determining insulin sensitivity, determining best time for administeringa drug with respect to another variable, such as meal(s), and the like.In step 208, a sampling group determination can be made as to whichinformation has to be collected, such as what biomarker(s) and thecontext(s) in which the biomarkers shall be collected, as well as whenthis information needs to be collected to conduct the analysis. Forexample, the sampling group can be defined as a string of data objects,each of which consists of: target type, e.g., time based which can use atarget time (e.g., used for an alerting feature), a lower time windowbound, an upper time window bound, etc., or data based which defines adata type (single, aggregate, or formula), the conditions for acceptingthe data (e.g., none, below a value, above a value, a formula, etc.),the type of collection (e.g., user input, sensor, data, etc.), as wellas any reminder screen text (e.g., static, and/or dynamic in bothformatting and value insertion) for each collection. The result of thisprocess is a schedule of collection events 222 (FIG. 5B). Next in step210, the manner in which each or a group of the schedule of collectionevents 222 is/are to be conducted in order to be useful for addressingthe situation or problem of the selected use case is then determined.This results in one or more adherence criterions 224. In addition toand/or instead of the manner for performing a collection, the adherencecriterion(s) 224 may also be based on one or more biomarker valuesfalling into a pre-defined range or is equal to a certain pre-definedvalue. In other embodiments, the adherence criterion(s) can be aformula(s) which uses a biomarker datum or group of such data todetermine if the resulting value falls into the pre-defined range or isequal to a certain pre-defined value.

For example, adherence criteria 224 can describe the parameters aroundthe data collection events 237 that the patient 12 needs to perform suchas tests within a certain window, fasting for a given amount of time,sleeping for a given amount of time, exercise, low stress, notmenstruating, etc. As such, an adherence criterion 224 can establish thecontext of the information about to be provided. Adherence criteria 224can also be used as mentioned above previously in another context toprovide an assessment of whether the data is acceptable and when used insuch a context may be referenced to as “acceptance” criteria. Forexample, before a sample is taken, the adherence criteria 224 canestablish whether steps leading up to taking of the sample areaccomplished. For example, the processor 102 in response to a request240 displays the question, “Have you been fasting for the last 8hours?”, wherein a “Yes” response received by the processor via the userinterface 146 meets the adherence criterion 224 for this step. Inanother example, after the sample is taken, the processor 102 can assessthe received data for reasonableness using other adherence (acceptance)criterion(s). For example, based on prior data, a fasting bG sampleshould be between 120-180 mg/dl, but the received value was of 340mg/dl, and thus fails such adherence (acceptance) criteria since beingout of the predefined range for an acceptable value. In such an example,an adherence event 242 occurs wherein the processor 102 could prompt foran additional sample. In such a case, if the re-sampling fails too(i.e., not between 120-180 mg/dl), the assessment provided by theprocessor 102 is that the patient 12 has not fasted, and thus theprocessor 102 as instructed by the adherence criterion upon a failing ofthe re-sampling extend automatically the collection events 237 in theschedule of collection events 222 accordingly.

In still other embodiments, the adherence criteria 224 can be used as alogical switch to decide which data values to display and which one notto display according to a desired quality or characteristic of the datacollected for each event 237. In one such embodiment, data valuescollected according to the schedule of collection events 222 which meetthe defined adherence criterion(s) 224 of the collection procedure 70can be designated automatically as viewable data by the processor 102 inthe data file 145, or vice versa in another embodiment. For example, theadherence criteria 224 in the collection procedure 70 can bepre-defined, and/or customized by the clinician as desired, to displayonly those data values which have a desired event quality orcharacteristic, such as, e.g., those data values which fall into adesired range or vice versa, those data values that are a particularvalue or vice versa, those data values taken within a particular timewindow or vice versa, those data values taken at a certain time or viceversa, those data values which shows a desired variation between aparticular number of previous data values collected from previous events237 or vice versa, those data values which shows a desired rate ofchange between a particular number of previous data values collectedfrom previous events 237 or vice versa, and combinations thereof. It isto be appreciated that providing such a logical switch via the use ofthe adherence criteria 224 in the collection procedure 70 provides theclinician with the flexibility to screen (i.e., filter) and display datavalues as needed in order to look at only particular data qualitymarkers in the collected data values. Such a feature is also useful in acollection procedure 70 which collects a large amount of data values,such as one that may be carried out over a very long period of time(e.g., 7 days or more), or when the collection device 24 is a continuousglucose monitor 28 providing a large amount of data values (i.e., 1000or more data values per day). A method of implementing such a displayswitching feature on the collection device 24 for a collected data valueis discussed herein after in a later section.

Next in step 212, the condition(s) and context(s) in which the scheduleof collection events 222 is to be started and ended can be determined.This results in one or more entry criteria 226 and exit criterions 228being provided for the schedule of collection events 222 as well aspossibly for a group of other schedule of events to which the scheduleof collection events 222 belongs if providing a package of structuredcollection procedures, e.g., procedures 70 a, 70 b, 70 c, and 70 d,which may run concurrently and/or sequentially one after the other.

For example, the one or more entry criteria 226 can be used to determinewhether the patient meets the conditions to use the collection procedureby the processor 102 checking that, for example, the patient 12 meetsthe entry criterion 226 based on current age being in a range, HbA1cbeing in a range, that the patient has a particular disease, has had thedisease over a minimum period of time, has a Body Mass Index (BMI) in arange, had a Fasting Plasma Glucose (FPG) in a range, had a particulardrug sensitivity, is taking a particular drug, taking a particular drugdosage, meets one or more prerequisites of another structured collectionprocedure, has completed one or more of another structured collectionprocedure, does not have one or more particular pre-conditions, e.g.,pregnant, not fasting, or contraindications, e.g., feeling ill,feverish, vomiting, etc., and combinations thereof. Entry criterion 226can also initiate the schedule of collection events 222 by an initiationevent such as a time of day, a time of week, meal, taking a meal with atime offset, exercise, and exercise with a time offset, use of atherapeutic drug, use of a therapeutic drug with time offset,physiological circumstances, biomarker range, and biomarker within apredetermined range calculated as an offset from a prior biomarkervalue. Example of a physiological circumstance can be that entrycriterion will be met to start a structured collection procedure when apre-determined number of a physiological event, e.g., hyperglycemia,hypoglycemia, a certain temperature at a certain of day, and the like,occur within a pre-defined amount of time, e.g., hours, day, weeks, etc.Accordingly, the entry criterion can be used to support the use of needto met prerequisites, indications for usage, and/or contraindicationsfor usage. For example, an entry criterion 226 could define aprerequisite condition which in order for the structured collectionprocedure 70 to run an Insulin Sensitivity optimization, the processor102 must verify first that a structured collection procedure for a Basaltitration is completed and/or has a desired result and/or as well asanother structured collection procedure for an insulin to carbohydrateratio is completed and/or has a desired result. In another example, anentry criterion 226 could be defined with needing to meet certainindications for usage in which certain structured collection procedurescould provide segregated uses for diabetics who are Type 1 vs. Type 2 aswell as types of structured collection procedures which can be used totitrate for specific drugs. In another example, the entry criterion 226could be defined with needing to meet certain contraindications forusage, in which for example, certain structured collection procedures 70will not run if the patient 12 is pregnant, sick, etc.

Examples of the one or more exit criteria 228 can be based on theprocessor 102 determining that a particular value is reached, that amean average of the primary samples values are in a range, that aparticular event(s) and/or condition(s) have or have not occurred, andcombinations thereof. Other conditions when the procedure may stop caninclude adverse events such as, for example, a hypoglycemic event, thepatient is sick, the patient undergoes a therapy change, and the likes.Additional detail may also by provided by the processor 102 on thedisplay 108 to the patient 12 based on what the specific exit criterionhas been met. For example, in one example, if the patient 12 measures aglucose value indicating hypoglycemia, upon exiting the procedure, theprocessor 102 run automatically another alternative procedure whichinstructs the patient 12 to ingest carbohydrates and measure his bloodglucose value every half an hour until the blood glucose exceeds 120mg/dL. For this alternative procedure, the patient 12 can also berequested by the processor 102 to document his meals, activity, stress,and other relevant details to ensure that the conditions that led tohypoglycemia are recorded. The patient 12 may also be instructed by theprocessor 102 to contact the clinician 14 in this and other such specialcases as deemed fit. Exit criteria can also include, for example,criterion for ending such as exiting after a successful completion, orexiting after an indeterminate completion, such as expiration of apredetermined timeout (logistical end), e.g., no result after n days,where n=1 to 365 days, or by termination e.g., exit with unsuccessfultermination due to a fail-safe. It is to be appreciated that thestructured collection procedure 70 can also be defined to endautomatically not only based on meeting the exit criterion 228, but alsowhen the patient 12 fails to perform a request to an acceptable level ofcompliance and/or when a patient physiological state has changed suchthat the patient is should not carry out the schedule of collectionevents 222, thereby failing adherence criteria 224, wherein theadherence event 242 is to end the structured collection procedure.

In step 214, guidance 230 for the user during collection can bedetermined as well as any options 232 for customizing the collection.For example, for guidance 230, the clinician 14 can use a default listof messages, or tailor messages to guide the patient 12 during executionof the structured collection procedure 70. As an example, one messagecould be provided on a successful data acquisition (i.e., meets theadherence criteria 224) would read, “Thank you. Your next scheduledmeasurement is at 12:30 pm.” Alarms, such as provided by indicator 148,can also be associated with the structured collection procedure 70 thatremind the patient 12 to take a measurement and can include a snoozefunctionality should the patient 12 need additional time to conduct themeasurement. The snooze functionality as well as other device featuresis discussed further in later sections.

The result of steps 208-214 is the structured collection procedure 70being created in step 216 which associates together the use caseparameter 220, the schedule of collection events 222, the adherencecriterion(s) 224, the entry criterion(s) 226, the exit criterion(s) 228,guidance 230, and the options 232. In one embodiment, at the time ofgenerating a structured collection procedure 70 the clinician 14 alsogenerates printed material (e.g., via computer 25) that explains to thepatient the following aspects (at a minimum): the purpose of thestructured collection procedure 70 and expected ideal outcome, i.e.,setting a goal for the structured collection procedure 70; thestructured collection procedure 70 design and the number of measurementsneeded; the entry criteria 226 that the patient 12 must satisfy beforeinitiating the structured collection procedure 70 and before taking eachreading; and the exit criteria 228 defining conditions under whichdevice 24 will or the patient 12 should cease to continue the structuredcollection procedure 70. Such printed material as well as the guidance230 that can be provided during the execution of the structuredcollection procedure 70 ensures that the patient is fully aware of whythe data collection procedure is being carried out.

Examples, of the structured collection procedure 70 may be, for example,a structured collection procedure for determining aninsulin-to-carbohydrate ratio, for determining bolus timing in respectto meal start, and for determining an exercise equivalent to ingestedcarbohydrates. In step 218, the structured collection procedure 70 isthen made available for implementation and use in the system 41, such asin any of the above discussed manners mentioned with regards to FIGS. 1,2, and 3. A structured collection procedure 70 accordingly may beprovided via the above process, such as by either the medical communityor healthcare companies 64, to help the clinician 14 address and/orinvestigate a defined medical use case or problem.

FIG. 5B shows the interactions of the parameters 222, 224, 226, and 228of the structured collection procedure 70 for obtaining contextualizedbiomarker data from a diabetic patient to address a medical use caseupon which the structured collection procedure is based. As mentionedabove, the use case parameter 220 may be provided to identify themedical use case or question to which the parameters 222, 224, 226, and228 address. For example, the processor 76 of the clinician computer 25,the processor 102 of the collection device 24, and/or the server 52 mayread the medical use case parameters 220 from a plurality of structuredcollection procedures 70 a, 70 b, 70 c, 70 d (FIG. 2), such as providedon these devices and/or within the system 41, and provide a list of theavailable structured collection procedures, such as on the display 82 ofthe clinician computer 25 or the display 108 of the collection device24. Additionally, the clinician computer 25, the patient computer 18,and/or the server 52 can use the medical use case parameter 220 forlocating/sorting/filtering such structured collection proceduresaccording to a medical use case(s).

As mentioned above, the entry criterion(s) 226 establishes therequirements for initiating the structured collection procedure 70 toobtain patient data which includes biomarker data, particularly,collected in a predefined context. In one embodiment, the processor 102of the collection device 24 can use the entry criterion(s) 226 todetermine when an associated structured collection procedure 70 isappropriate for the patient's physiological context and to ensure thatall of the necessary inputs to the associated structured collectionprocedure have been established. Therefore, it is to be appreciated thatthe start date and/time of a structured collection procedure maydynamically change automatically by the processor 102 of the collectiondevice 24 if the predefined condition(s) of the entry criterion(s) 226is not satisfied. Accordingly, until the entry criterion 226 issatisfied, the start date and/time of the associated structuredcollection procedure 70 can be at some unknown time in the future.

For example, in one embodiment, a structured collection procedure 70 canbe chosen automatically by the processor 102 from a plurality ofstructured collection procedures 70 a, 70 b, 70 c, 70 d, such asprovided in memory 110 of the collection device 24, memory of thecomputers 18, 25 and/or from server 52, based on satisfying thecondition(s) of a defined entry criterion 226 for an associatedstructured collection procedure. For example, in one embodiment, a firststructured collection procedure, such as procedure 70 d, is useful forshowing trends in blood glucose levels (“bG Level Trending”). Therefore,an entry criterion 226 for the first structured collection procedure 70d may be for the patient to have a bG level mean which has elevated overa defined period (e.g., a past number of days, weeks, and months fromthe current date) above a certain pre-defined rate. For a secondstructured collection procedure, such as procedure 70 a, its entrycriteria 226 may require a particular number of bG measurement for apre-breakfast measurement over a defined period (e.g., a past number ofdays, weeks, months, from the current date) being below a pre-defined bGvalue. In such an example, the processor 102 upon start up in oneembodiment when commanded, such as via input received via the userinterface, in another embodiment, or at a scheduled time as programmedby the software 34 in another embodiment, can run through the variousentry criteria 226 provided by the various structured collectionprocedures 70 a and 70 d that are, for example, provided in memory 110of the collection device 24 and determine whether the statedcondition(s) for the entry criteria 226 of a particular structuredcollection procedure 70 is satisfied. In this example, the processor 102determines that the historical data from past measurements in memory 110indicate that the patient's bG level mean has been elevating, and thatthe entry criterion 226 for the first collection procedure 70 d has beenmet, but not the entry criteria for the second structured collectionprocedure 70 a. In this example, the processor 102 then automaticallyselects and starts the first structured collection procedure 70 d basedon the above-mentioned analysis.

It is also to be appreciated that the use of the entry criterion 226 canhelp to reduce the misallocation of medical expenses by assuring thatthe indications of use for the structured collection procedure 70 havebeen met before starting the schedule of collection events 222. Theentry criterion 226 as well can help assure that any requests to performmultiple structured collection procedures do not overlap ifincompatible, are not unnecessary repeats of each other, or provide asignificant burden on the patient. In this manner, many of the notedproblems in which a patient may avoid any further attempts to diagnosetheir chronic disease or to optimize therapy can be both addressed andavoided automatically by the processor 102 of the collection device 24via use of the entry criterion 226.

As shown by FIG. 5B, the entry criteria 226 can include context specificentry criterion 234, procedure specific entry criterion 236, andcombination thereof. Examples of context specific entry criterion 234can include one or more variables to identify meals, low blood glucoseevents, insulin type and dosage, stress, and the like. In anotherexample, the context specific entry criterion 234 can be defined such asin the form of a specific question(s), to which the processor 102requires a specific answer to be received from patient via input fromthe user interface 146. For example, the processor 102 in executing theentry criterion 226 may display on the display 108 the question ofwhether the patient is willing and able to perform the structuredcollection procedure 70 over the required period. If the patientresponses affirmatively via the user interface 146, then the entrycriterion 226 has been satisfied and the processor 102 continuesautomatically with performing the collection events 237 according to thetheir associated timing as defined in the structured collectionprocedure 70. If the patient responses in the negative to the displayedquestion, then the processor 102 will not continue with the structuredcollection procedure 70, and may for example, re-schedule the asking ofsuch a question to a future time, such as if designated by an optionsparameter.

Examples of procedure specific entry criterion 236 can include one ormore variables to identify disease state, disease status, selectedtherapy, parameter prerequisites, insulin to carbohydrate ratio prior totesting insulin sensitivity, incompatible collection procedures, and thelike. In one embodiment, the procedure specific entry criterion 236 canbe defined such that the processor 102 will continue automatically withthe structured collection procedure 70 with one of three initiators—thepatient 12, the clinician 14, or data, e.g., if the condition(s) of theentry criterion 226 is satisfied. For example, the procedure specificentry criterion 236 can be satisfy if the clinician 14 has prescribedthe structured collection procedure 70, such as via an authorized userentering via the user interface 146 a valid password to unlock theparticular structured collection procedure for use, in one embodiment.In another embodiment, the clinician 14 can send the password or anauthorization code from clinician computer 25 and/or server 52 to thecollection device 24 which prescribes (authorizes) the structuredcollection procedure 70 for use by the patient 12 on the collectiondevice 24. It is to be appreciated that one or more structuredcollection procedure 70 can be provided in memory 110 of the collectiondevice 24 which cannot be used by the patient 12, and which can be alsohidden from being viewed on the display 108, such as in a selectionlist, by the patient until authorized by the clinician 14. In stillanother embodiment, the clinician 14 can be also an authorized user,e.g., who can enter via the user interface 146 a valid password tounlock the particular structured collection procedure for editing,wherein the rights for editing and the rights can be differentiated byentering different passwords.

The procedure specific entry criterion 236 can be satisfied by a userfor example, by the user selecting a particular structured collectionprocedure 70 from a listing of structured collection procedures 70 a, 70b, 70 c, 70 d provided on the display 108. An example of a datainitiated procedure for the procedure specific entry criterion 236 wouldbe that a biomarker measurement(s) provided to the processor 102indicates a certain condition which must have occurred or be present inorder for the entry criteria 226 for the particular structuredcollection procedure to be satisfied. Such a condition, for example, canbe the occurrence of a single event, such as a severe hypoglycemicevent, or a series of events, such as hypoglycemic events within agiven, a predetermined time frame, such as in 24 hours from a starttime, in one week from a start time, etc., a calendar date-time, and thelike. In still other embodiment, the entry criteria 226 for a particularstructured collection procedure can be satisfied by also meeting a starttime, e.g., a pre-defined time, calendar date-time, and the likes.

Accordingly, the entry criteria 226 can be a single criterion ormultiple criteria that establish context and/or condition of thepatient's physiology that are relevant to the medical use case beingaddressed by the structured collection procedure 70. In anotherembodiment, the entry criteria 226 can be assessed after patient datahas been collected, such as, on historical patient data.

The schedule of collection events 222 specifies one or more collectionevents 237 which each comprises at least one or more variables defininga performance time or timing 238, the guidance 230 to perform the event,requests 240 for patient actions, which may include a request forinformation from the patient and/or a request for collection of at leastone type of biomarker data from the patient, and combinations thereof.For performance time 238, the schedule of collection events 222 canspecify timing of each collection event 237, such as for a biomarkersampling at a particular time on three consecutive work days, or onesample at time of wake-up, one sample thirty minutes later, and anothersample one hour later.

The guidance 230 for each collection event 237 and for any criteria 224,226, 228 may include, for example, providing electronic reminders(acoustic, visual) to start, end and/or wake up at a particular time, toperform a bG collection at a particular time, to ingest a particularmeal or food(s) at a particular time, to perform a certain exercise(s)at a particular time, take medication at a particular time, and thelike. Guidance 230 may also include information, questions and requeststo record particular information about physiology, health, sense ofwell-being, etc., at a particular time, suggestion to improve compliancywith the collection procedure, encouragement, and positive/negativefeedback.

It is to be appreciated that the collection events 237 define all thesteps that are necessary to be preformed in advance of as well as aftera biomarker sampling according to a request 240, such that areproducible set of circumstances, i.e., context before and/or after thesampling, is created in the biomarker data for the biomarker sampling.Examples of such biomarker data, in the context of diabetes, includefasting blood glucose values, pre-prandial glucose values, postprandialglucose values, and the like. Examples of a set of circumstances caninclude data associated with the biomarker value which identifiescollected information in the patient data about meals, exercises,therapeutic administration, sleep, hydration, and the likes.

Each of the collection events 237 in the schedule of collection events222 can be time-based, event-based, or both. A collection event 237 canalso be a start of a meal, a wake-up time, start of exercise, atherapeutic administration time, a relative offset used with a priorglucose value, or a time indicating movement above or below apredetermined biomarker value threshold. The collection events 237 canalso include any required patient actions necessary to be performed inadvance of and during biomarker sampling such that reproduciblecircumstances are created at the time of biomarker sampling. This canincludes one or more of meals, exercise, therapeutic administration,sleep, hydration, and the like. Additionally, the collection events 237in the schedule of collection events 222 can be adjusted (number, types,timing, etc.), to accommodate work schedule, stressors, and the like ofthe patient 12.

As mentioned above previously, the adherence criteria 224 is used toassess qualitatively whether a collection event 237 performed accordingto the schedule of collection events 222 provided data which isacceptable to addressing the medical use case upon which the structuredcollection procedure 70 is based. In particularly, the adherencecriteria 224 can provide variables and/or values used to validate datafrom a performed collection event 237. For example, an adherencecriterion 224 can be a check performed by the processor 102 of thecollection device 24 that a value collected in response to a collectionevent 237 is within a desired range, or is above, below, or at a desiredvalue, wherein the value may be a time, a quantity, a type, and thelike. The same or different adherence criteria 224 may be associatedwith each of the collection events 237 within the schedule of collectionevents 222 as well with the entry criterion(s) 226 in one embodiment,and as being the exit criterion 228 in another embodiment, such asillustrated by FIG. 6D (i.e., “stop exercising when bG back in targetrange” which defines both the adherence and exit criteria). In oneembodiment, one or more collection events 237 in the schedule ofcollection events 222 may be modified (e.g., added, deleted, delayed,etc.) if a particular event or events fail to met the adherencecriterion 224 for the particular event or events. In one embodiment, themeeting of an adherence criterion(s) 224 for a particular event 237 cantrigger an adherence event 242. In one embodiment, upon occurrence of anadherence event 242 due to the associated adherence criterion(s) 224 fora collection event 237 being met or satisfied, the processor 102 sendsautomatically a message to the clinician 14 notifying him or her of thepatient 12 meeting the associated adherence criterion(s) in oneembodiment as well as providing the context data associated with themeeting of the adherence criteria 224 in still another embodiment. Inanother embodiment, the failure of the adherence criterion(s) 224 for aparticular event can trigger an adherence event 242. In one embodiment,upon occurrence of an adherence event 242 due to the associatedadherence criterion(s) 224 for a collection event 237 not being met orsatisfied, the processor 102 sends automatically a message to theclinician 14 notifying him or her of the failure of the associatedadherence criterion(s) in one embodiment as well as any context dataassociated with the failure of the adherence criteria 224 in stillanother embodiment. In yet another embodiment, upon occurrence of anadherence event 242 due to the associated adherence criterion 224 for acollection event 237 not being met or satisfied, the processor 102 maybe required one or more additional actions as a consequence. Forexample, the processor 102 may prompt on the display 108 additionalinformation to the patient, and/or prompt a question to determinewhether the patient 12 is sick, stressed, or unable to perform therequest e.g., eat the meal, or exercise. If the patient answers “Yes”,e.g., via the user interface 146, then as part of the adherence event242 the processor 102 can provide a delay to the schedule of event (i.e.suspend). In one embodiment, the delay can continue until the patientindicated that he or she is better in response to another questionprompter by the processor 102, such as the next day or after apredefined amount of time as also part of the adherence event. Forexample, the patient 12 is prompted by the processor 102 to administer adrug, but the patient is not at home, such as for example, where his/herinsulin is located. The patient 12 can select the delay via the userinterface 146, wherein the processor 102 re-prompts the patient after apredetermined amount of time. This delay may also have an upper limit inwhich if the schedule of events is not re-started within a certainamount of the time, the structured collection procedure 70 in such acircumstance may just end. In another embodiment, another form of anadherence event is a violation event, which results when the personexecuting a structured collection procedure 70 fails to make arecommended change in response to a request. For example, the requestmay be for the patient to adjust a drug dosage from 10U to 12U, whereinthe patient answers in the negative to a question on the displayed onthe display 108 asking if the patient will or has complied with such achange. In response to such a violation event, the processor 102 mayalso send a message, for example, to the clinician 14, and/or provide adelay as previously discussed above concerning the adherence event.

In another example and in one embodiment, a bG measurement must becollected before each meal in order for a structured collectionprocedure 70 to provide data that is useful in addressing the medicaluse case or question for which it was designed, such as identified bythe use case parameter 220. If, in this example, the patient fails totake a bG measurement for the lunch meal in response to a request 240for such a collection according to the timing 238 of the collectionevent 237, and hence the adherence criteria 224 for that collectionevent 237 fails to be satisfied, the processor 102 in response to theassociated adherence event 242 can be programmed according toinstructions in the structured collection procedure 70 to cancel allremaining collection events 237 in the schedule of collection events 222for that day, mark the morning bG measurement stored in the data file(such as data file 145 (FIG. 4) as invalid, and reschedule the scheduleof collection events 222 for the next day. Other examples of furtheractions in which the processor 102 may take in response to an adherenceevent 242 may be to dynamically change the structured collectionprocedure by switch to a secondary schedule of event, which may beeasier for the patient to perform, provide additional events formeasurements to make up the missing data, change the exit criteria froma primary to a secondary exit criterion providing modified criterion(s),change the adherence criteria from a primary to a secondary adherencecriterion, fill in the missing data for the failing event with (anestimate from) historical data, perform a particular calculation to seeif the structured collection procedure 70 can still be successfullyperformed, send a message to a particular person, such as a clinician,of the failing event, provide a certain indication in the associateddata record 152 to either ignore or estimate the missing data point, andthe likes. In still another embodiments, the adherence criteria 224 canbe dynamically assessed, such as for example, based on one or morebiomarker values and/or input received from the user interface inresponse to one or more questions, via an algorithm which determineswhether the collected data provides a value which is useful inaddressing the medical use case or case. In this example, if thecalculated adherence value is not useful, for example, does not fallinto a desired range or meet a certain pre-define value, then furtherprocessing as defined by the resulting adherence event would then takeplace, such as any one or more of the processes discussed above.

The exit criteria 228 as mentioned previously above establishes therequirements for exiting or completing the structured collectionprocedure 70. In one embodiment, the exit criteria 228 can be used toensure that the structured collection procedure 70 has adequatecontextual data to answer the medical question addressed by thestructured collection procedure 70. In such an embodiment, the exitcriterion 228 thus can help increase the efficiency of the structuredcollection procedure 70 by minimizing the number of required samplesneeded to address the medical use case. By “addressing”, it is meantthat sufficient patient data has been collected in which the clinician14 may render an assessment to the medical use case. In otherembodiments, the assessment may be indicated by a given confidenceinterval. A confidence interval is a group of discrete or continuousvalues that is statistically assigned to the parameter. The confidenceinterval typically includes the true value of the parameter at apredetermined portion of the time.

As with the entry criteria 226, the exit criteria 228 can comprise oneor more of context specific exit criterion 244, procedure specific entrycriterion 246, and combinations thereof. Examples of context specificexit criterion 244 can include one or more variables to identify mood,desired blood glucose events (i.e., blood glucose level), to indicatestress, illness, contraindications, such as for example, hyperglycemia,hypoglycemia, vomiting, a fever, and the likes. Examples of procedurespecific entry criterion 246 can include one or more variables toidentify a number of events meeting the adherence criteria, biomarkervalues being in a desired pre-determined range and/or at a desiredpre-determined value, a desired disease state, desired disease status,no change in the biomarker after a pre-determined period, or nosignificant progress over a pre-determined period to a desired biomarkervalue, a predefined date-time, and the like. It is to be appreciatedthat in one embodiment the exit criterion 228 can establish thecondition(s) needed to be met for entry criterion 226 of a secondstructured collection procedure 70. For example, upon having a suitableInsulin-to-Carbohydrate (I:C) determined with a first collectionprocedure, such as for example, structured collection procedure 70 b(FIG. 6B), running a structured test for determining the best time foradministering a bolus in regards to a start of a meal, such as forexample, structured collection procedure 70 c (FIG. 6C), which needs acurrent I:C ratio, can be conditioned such that the processor 102 canimplement automatically a schedule of events of the second structuredcollection procedure 70 c upon meeting the exit criterion of the firststructured collection procedure 70 b, which can be in one particularembodiment, after a pre-defined date-time, or in another embodiment atsome unknown time if the conditions for meeting the exit criteria isdependent on non-date time condition(s). For example, the exit criterion228 of a first structured collection procedure 70 that is being run bythe processor 102 according to the schedule of collection events 222 andthe entry criterion 226 of the second structured collection procedure 70both can be based on the same one or more contraindications, such asmentioned above. In such an embodiment, upon occurrence of acontraindication being provided to and/or detected by the processor 102,such as via the user interface 146 and/or the biosensor 140,respectively, which in this example meets the exit criterion 228 of thefirst structured collection procedure 70, the processor 102 wouldautomatically start the schedule of events of the second structuredcollection procedure 70 as the entry criterion 226 of the secondstructured collection procedure 70 has also been met. An example of sucha second structured collection procedure 70 which can be started viaexiting a first structured collection procedure can be one which has aschedule of collection events 222 which requests a biomarker samplingsat a routine interval, e.g., every 30 minutes, every hour, every day ata particular time, etc., until the contraindication(s) clears (e.g.,biomarker value(s) reaches a desire range or value, patient 12 indicatesto processor 102 via user interface 146 no longer having acontraindication(s), expiration of a predefined period, etc.). Such anembodiment is useful if recording the context and values of the eventsafter the occurrence of the contraindication(s) is a desire and in whichthe first collection procedure should be exited when acontraindication(s) occurs.

The exit criteria 228 can be a single criterion or multiple criteriathat establish the conditions to exit the structured collectionprocedure 70. The conditions are provided in a preferred embodiment suchto ensure that adequate contextualized biomarker data has been obtainedto answer the medical question being addressed by the collection method.For example, such that a predetermined number of valid samples have beenacquired, or that the variability in the samples is below apredetermined threshold. Therefore, in such an embodiment the end dateand/time of the structured collection procedure 70 may be dynamic and bechanged automatically by the processor 102 if the predefinedcondition(s) of the exit criterion(s) 228 is not satisfied. Likewise, inanother embodiment, the conditions of the exit criterion 228 may bedynamic and be changed automatically be the processor 102 such forexample if a particular adherence criterion 224 is satisfied or notsatisfied. For example, in one embodiment if adherence criterion 224 fora particular collection event 237 is met, then the processor 102 isinstructed to use a first exit criterion and if not met, then theprocessor 102 is instructed to use a second exit criterion that isdifferent from the first exit criterion. Accordingly, until the exitcriterion 228 is satisfied in such embodiments, the end date and/time ofthe structured collection procedure 70 can be at some unknown time inthe future. In another embodiment, the exit criteria 228 can be assessedafter patient data has been collected, such as, on historical patientdata.

It is to be appreciated that the entry and exit criteria 226, 228together with the adherence criteria 224 can help to reduce both thetime to perform the structured collection procedure 70 and the expenseassociated with the collection by defining one or more of the acceptableconditions, values, structure and context needed to perform the scheduleof collection events 222 in an effort to make every collection event 237count and/or reduce consumption of test strips 30 with unneededcollections that do not help address the medical use case or question.Hereafter reference is made to FIGS. 6A-6E.

Structured Collection Procedure Examples

FIGS. 6A-E illustrate examples of some structured collection procedures70 a, 70 b, 70 c, and 70 d depicting their functions which can easily betranslated by one of ordinary skill in the related art into instructioncode which may be implemented on any one of the devices the abovedescribed devices 18, 24, 25, 26, 28, 36, 52. Therefore, for brevity, nodiscussion is provided concerning pseudo-code or actual code relating tothese illustrated functions.

FIG. 6A diagrammatically illustrates an embodiment of a structuredcollection procedure 70 a used to obtain contextualized biomarker datafrom a diabetic patient. The horizontal axis shows the performance times238 of the various collection events 237, and the vertical axis showsadherence criterion 224 without values. In the illustrated embodiment,the collection events 237 can include recording information regarding ameal 248 and sleep 250 in which to provide context 252 for thefive-biomarker samplings 254 also collection events 237 that are part ofthe schedule of collection events 222. In this example, the adherencecriterion 224 for the meal 248 can be a value which must be greater thana minimum value, e.g., for a carbohydrate amount. The entry criterion226, for example, can comprise a biomarker value being above aparticular value such as required to meet contextualization requirementsto begin the structured collection procedure 70 a. The exit criterion228 as well can comprise a biomarker values being below a particularvalue such as also required to meet contextualization requirements toend the structured collection procedure 70 a. Such a structuredcollection procedure 70 is useful for helping to address a number ofmedical use cases.

GLP1 Structured Collection Procedure

For example, several epidemiological studies have confirmed thatelevated postprandial glucose (PPG) levels are a significant predictorof cardiovascular mortality and morbidity in type 2 diabetes (T2D). Forthis reason, there is a family of human once-weekly long actingglucagon-like peptide-1 (GLP 1) drugs which can be prescribed to T2Dswho show high post prandial bG values. These GLP 1 drugs are similar tothe natural hormone GLP-1 which has a key role in blood sugar regulationby stimulating insulin secretion and suppressing glucagon secretion.Therefore, a structured collection procedure 70 can be provided in oneembodiment which proposes an intensive measurement of bG values duringthe time after one or more meals over time allows therapy efficacy to beshown by means of observed reduced postprandial bG values. Based on suchobserved values, doses recommendation for a GLP 1 drug and/or whether aparticular GLP 1 drug is the right drug at all for the patient can bedetermined.

For example, the structured collection procedure 70 could be provided ona collection device 24 for when a patient has been prescribed toadminister a particular drug, e.g., a GLP 1 drug. In the case of a GLP 1drug, in which determination of drug efficacy is desired, the entrycriterion 226 for such a structured collection procedure could then bethat the patient must affirm to the processor 102 in response to aquestion displayed on the display 108 to perform the structuredcollection procedure 70 over a period of time (e.g., over the next 4 to24 weeks) and/or the processor 102 has determined that the mean PPGlevel of the patient from prior post prandial bG values over a period(e.g., week, month, etc.) are high (e.g., greater than 141 mg/dl). Stillother factors could be used as the entry criterion(s) 226, such asfasting blood glucose being more than a certain value, e.g., 126 mg/dlor less than a certain value, e.g., 240 mg/dl.

After the conditions of the entry criterion(s) 226 have been satisfiedand confirmed by the processor 102, the schedule of collection events222 is then automatically run by the processor 102. The schedule ofcollection events 222 would specify desired collection events 237 inwhich the processor 102 would automatically prompt the patient forentering post prandial bG values after breakfast, lunch, and dinner(i.e., performing a bG measurement on a sample provided to a test stripthat is read by the measurement engine and provided to the processor forstoring in a data record and display). As customized by the prescribingclinician, the schedule of collection events 222 could also define acollection event 237 with a performance time 238 in which the patientmust administer the drug as well as to provide a reminder of the dosageand a request 240 for confirmation from the patient when the drug hasbeen administered. For example, the processor 102 in executing theschedule of collection events 222 would automatically prompt the patientto administer dosages at the times specified by the collection events237 in the schedule of collection events 222, e.g., 10 mg ofTaspoglutide on a certain day of the week, and then after a period, asecond dosage according to a second interval, e.g., after 4 weeks, then20 mg also on a certain day of the week. A collection event 237 couldalso be defined in the schedule of collection events 222 in which theprocessor 102 makes a request on the display 108 for information, suchas whether the patient is feeling well, to provide an indication ofenergy level, to provide an indication of size of meals consumed, andthe like.

A condition(s) for the adherence of each entered post prandial bG valuecould be provided via the use of adherence criteria 224 in which anypost prandial bG value entered (i.e., measured) an amount of time beforeor after the prompting, e.g., a testing window of ±30 minutes, such ameasured value would not be accepted as a valid measurement for theschedule of collection events 222 by the processor 102. In oneembodiment, the processor 102 can take further action automaticallybased on the adherence criteria 224 assessment preformed automaticallyby the processor 102. For example, if a bG measurement was taken beforea measurement prescribed by a collection event in the schedule ofcollection events 222 and outside the defined testing window, e.g., −30minutes before the collection event time, the processor 102 in such acase will automatically notify the patient that a measurement is stillneeded at the prescribed time as the previous measurement was notaccepted since outside the testing window. Likewise, if after thetesting window, e.g., the collection event time +30 minute, theprocessor 102 can automatically notify the patient that the previousmeasurement was not accepted since outside the testing window andprovide encouragement on the display 108 to the patient to make aneffort take a measurement within the testing window.

The exit criterion 228 for such a GLP 1 structured collection procedure70 could be an indication that the mean bG value, in using a minimumamount of time (e.g., days, weeks, months, etc.), a minimum number ofaccepted measurements, or both, has reached a desire value. Likewise,the exit criterion 228 could be an indication that the mean bG value,after a maximum amount of time (e.g., days, weeks, months, etc.), amaximum number of accepted measurements, or both, has not reached adesire value. Still further, the exit criterion 228 can be other factorswhich indicate that the drug or dosage is not at all right for thepatient, such as the patient responding as having nausea and/or vomitingeach day for a minimum number of days in response to a collection eventfor such information prompted by the processor 102 on the display 108.Still other factors could be used as the exit criteria 228, such asfasting blood glucose being less than a certain value, e.g., 126 mg/dlor greater than a certain value, e.g., 240 mg/dl. The data collectedfrom such a drug base structured collection procedure 70 can then beused by a clinician to make a dosage recommendation for the GLP 1 drugand/or determine whether the particular GLP 1 drug is the right drug ornot for the patient.

Another example is diagrammatically depicted by FIG. 6B which shows astructured collection procedure 70 b which has a defined medical usecase parameter 220 indicating that the procedure can be helpful fordetermining suitability of an insulin to carbohydrate (I:C) ratio. Asillustrated, the entry criterion 226 is defined as having the patientsimply acknowledge guidance 230 of selecting a fast-acting meal, to notethat the insulin dose is calculated with the current I:C ratio as wellas agreeing not to exercise, take additional food or insulin during thetesting period. For example, the processor 102 can present on thedisplay 108 such guidance 230, which the user can then acknowledge afterreading with either a “Yes” or a “No” entered via using the userinterface 146 for the desired entry choice. If the user enters “Yes”,then the entry criterion 226 is satisfied, and the processor 102automatically starts the schedule of collection events 222 defined inthe structured collection procedure 70 b. In another embodiment, theentry criterion 226 may be or include satisfying a request 240 forselecting a fast-acting meal. For example, the request 240 for selectioncan be the processor 102 displaying on the display 108 a selection menuproviding a listing of fast-acting meals to which input of such aselection via the user interface 146 is needed. For example, selectionof a fast-acting meal may be made via a press of one of the buttons 147,149 or via the touch screen interface if provided by display 108. Such aselection can then be stored in memory 110 of the collection device 24such as setup data 163 (FIG. 4) which may be part of the data file 145(FIG. 4) for the structured collection procedure 70 b. In an alternativeembodiment, a particular fast-acting meal may be recommended by thestructured collection procedure 70 b.

As shown, the schedule of collection events 222 can comprise one or moreevents, such as the plurality of collection events 237 a-k illustratedand with each having associated performance times 238 a-k and requests(for action) 240 a-k. As shown, the requests for action 240 a-c and 240f-k are requests for the user to take a bG level measurement, request240 d is to take an insulin dose, and request 240 e is to eat the fastacting meal. Also shown is that events 237 f-k each have an adherencecriterion 224, which must be met if the data for events 237 f-k are tobe recorded in the data file 145. In this example, the adherencecriteria 224 requires that the requests 240 f-k be completed within ±20minutes of their corresponding performance times 238 f-k in order for adata record 152 recording the received value(s) for the correspondingcollection event 237 f-k to count towards completing the structuredcollection procedure 70 b. In one embodiment, the processor 102 willmake each of the requests 240 a-k at their associated performance times238 a-k in order to obtain resulting data values e.g., data 256 a-k(FIG. 4) at the time the requests are performed.

For example, the processor 102 can prompt the patient 12 with a request240 a to take a bG level (biomarker) measurement at performance time 238a. The resulting measurement when received by the processor 102, such asautomatically from the measurement engine 138 after reading the teststrip (bio sensor) 140 for the desired biomarker, is then recordedautomatically by the processor 102 in the date file 145 as acorresponding data value 256 a for the associated collection event 237a. For requests 240 d and 240 e, at a required time, the processor 102can automatically prompt the patient 12 to take the prescribed action atthe required time, and again automatically prompt the patient thereafterto confirm that the required action has been taken, or that a predefinestatus has been achieved. A date-time stamp 169 can also be provided inthe date record 152 automatically by the processor 102 upon triggeringof the requests 240 a-k, acknowledgement of the requests 240 a-k, uponcompletion of the collection event 237 a-k, upon receiving a data value256 a-k for the collection event 237 a-k, and combinations thereof.Additionally, in another embodiment, the patient 12 can record datavalues 256 a-k for one or more collection events 237 a-k by entering thedata directly into the collection device 24 via the user interface 146,wherein the processor 102 stored the entered data values/information inthe associated data record 152 for the collection event 237 a-k, or inother embodiments can record a voice message with the information forlater transcription into digital data. In still other embodiments, thepatient 12 can be guided by the collection device 24 to record data fora collection event 237 a-k using a paper tool 38.

As mentioned previously above, each collection event 237 can be arecording of a biomarker value, or a request for a required patientaction that is necessary in order to create a context for the biomarkervalue, such as for example, meals, exercise, therapeutic administration,and the like. In the illustrated embodiment, the context 252 forcompleting collection events 237 a-c is to establish a pre-prandialbaseline and a no-trend condition, and for collection events 237 f-k toestablish a post-prandial excursion and tail. Such context 252 for theseevents may also be associated with the corresponding data records 152for each event as contextual information 156 (FIG. 4). Such informationis useful later when reconstructing the data and/or when there is adesire to know the context for which the data record was created.

It is to be appreciated that any patient action taken outside of therequired requests 240 a-k can also be recorded by the processor 102 butwill not be considered by the processor 102 as part of the structuredcollection procedure 70 b. Data 256 a-k for collection events 237 a-kthat are prospective can be identified based on a type of event, thetime of the event, the trigger of the event, and combination thereof.Each of the performance times 238 a-k can be fixed or variable based onprior data. Some of the collection event 237 a-k in other embodimentscan also be a past, current, or a future event such as for meals,exercise, and the like, or data values such as for hypoglycemic events,hyperglycemic events, or data of a specific value of interest. In someembodiments, the collection events 237 a-k can be identified via a papertool 38 that is procedure based.

As also shown, the structured collection procedure 70 b will end if thecondition of the exit criterion 228 is satisfied. In this example, theexit criterion 228 is satisfied if at least three of the requests 240f-k met the adherence criterion 224. For example, the processor 102 mayprovide a unique identifier 167 (e.g. a unique identifier (e.g. one ormore numbers, letters, and/or characters which will only appear once inthe data file to identity data associated therewith, e.g., anincremental count, pointer, etc.) (FIG. 4) in the data file 145 for eachcollection event 237 a-k performed and to which satisfied the adherencecriterion 224 if required. In the illustrated embodiment of FIG. 4,collection events 237 a-c and 237 e-k each receive a unique identifierbut not collection event 237 d, e.g., <null>, since not satisfying anassociated adherence criteria (not shown). In addition, analysis logic258 and resulting recommendations 260 can also be provided in thestructured collection procedure 70 b which the processor 102 may applyautomatically to the data collected upon satisfying the exit criterion228 in one embodiment.

Similar features are also provided in the examples illustrated by FIGS.6C and 6D, wherein FIG. 6C depicts a structured collection procedure 70c which has a defined medical use case parameter 220 indicating that theprocedure is helpful for determining suitability of a bolus in regardsto a meal start. Likewise, FIG. 6D depicts a structured collectionprocedure 70 d which has a defined medical use case parameter 220indicating that the procedure is helpful for determining suitability ofan exercise equivalent to a carbohydrate intake. In addition to theabove examples, other such structured collection procedures may bedesigned to address other various medical use cases such as, forexample, the following: determining the effects of eating a particularfood on a biomarker level of a patient; determining the best time totake medication before and/or after a meal; and determining the affectof a particular drug on a biomarker level of a patient. Still otherstructured collection procedures can be provided which may be useful inaddressing questions concerning how best to initialize therapy for apatient, finding a determination of status of a patient diseaseprogression, finding the best ways to optimize a patient therapy, andthe like. For example, the clinician 14 can define and/or use apre-defined structured collection procedure 70 which looks at factorswhich may have an effect on the therapy of the patient. Such factors caninclude, for example, stress, menstrual cycle, pre-dawn effect,background insulin, exercise, bolus timing with respect to a meal, basalrate, insulin sensitivity, post-prandial behavior, and the like.

FIG. 6E shows a diagram structured collection procedure 70 comprisingone or more multiple sampling groupings 262 each comprising a recurringschedule of collection events 222 provided between the entry criterion226 and the exit criterion 228. In this example, the schedule ofcollection events 222 comprises one or more collection events 237occurring each day at consistent times of day. As the structuredcollection procedure 70 in the process of obtaining contextualizedbiomarker data from a diabetic patient 12 can span over multiple days,even week and/or months before the exit criterion 228 is met, one ormore checks 264, such as for parameter adjustment, and/or evaluation ofwhether to re-run the sampling groupings 262, can also be providedbetween the entry and exit criterions 226, 228 in one embodiment. Theduration between such checks 264 can be used for physiological systemequilibration, evaluation of treatment efficacy, or convenience. Forexample, either between each sample grouping 262, or after a predefinednumber such sampling grouping 262 (as shown), an analysis for the check264 can be performed by the processor 102 to determine whether anadjustment to any parameter in the structured collection procedure 70 isneeded.

For example, such analysis may be either for a parameter optimization orefficacy assessment. For the parameter optimization, the processor 102can run calculations on the samples provided within a previous scheduleof collection events 222 or sample grouping 262, using information fromprior optimizations, clinician set parameters, and a collection ortherapy strategy, recommends a new parameter value. For the efficacyassessment, the processor 102 can evaluate data not utilized by theoptimization analysis. Additionally, it is to be appreciated that aftera group of samples, i.e., sampling group 262, are taken the processor102 can also evaluate the data from the sampling group 262, such as ifsuch data is need in order to alter/optimize a person's therapy.Adherence criteria can be applied to the perform this evaluation to thedata of the sampling group 262. For example, a first adherence criterion224 can be used by the processor 102 to assess whether a minimum amountof data is provided by the sampling group 262 and if not, for example,the alteration/optimization of the patient's therapy will not takeplace. Another adherence criterion 224 could permit the processor 102 toassess whether the data is acceptable to permit an adjustment called forby the check 264, such as looking at spread of the data, whether thereis too much variability (noise), as well as other data attributes to usethe data. In this example, if meeting such adherence criterion, then theprocessor 102 has assessed that there is minimum risk that adjusting aparameter of the procedure could readily result in a severe event, e.g.,hyper- or hypoglycemic event. Lastly, an adherence criterion can be usedby the processor 102 to assess the exit criteria based on the data ofsampling group, for example, the exit criterion is met when the datafrom the sampling group 262 satisfies the adherence criterion, such asfor example, discussed above, for the sampling group.

It is to be appreciated that collection or therapy strategies can becategorized into scale based (sliding or fixed) assessments or formulabased assessments. As input to the collection or therapy strategy, theprocessor 102 in one embodiment can utilize the data collected from apredetermined number of prior sample grouping(s) 262. This data can beeither used as individual points (only the formula based collection ortherapy strategies), or combined with filtering for use in a scale basedassessment. In another embodiment, for example, the result of a check264 performed by the processor 102 can also result in a status orrecommendation being provided by the processor 102 automatically. Suchstatus or recommendation may be e.g., a status of continuing withcurrent parameter values, a recommendation to change particularparameters, a recommendation to change the adherence and/or exitcriterion, a status that the processor 102 switched to a secondaryadherence and/or exit criterion based on the analysis performed on thedata from a prior schedule of events or prior sample grouping, or arecommendation to terminate the collection procedure, and the likes. Adiscussion of performing a structured testing method using a structuredcollection procedure according to an embodiment of the present inventionis provided hereafter with reference made to FIG. 7A.

Structured Testing Method Using a Structured Collection Procedure

FIG. 7A depicts a structured testing method 300 for diagnostic ortherapy support of a patient with a chronic disease through the use of astructured collection procedure. The method 300 may be implemented asinstruction codes of a program running on a computer with a processorand memory, such as preferably clinician computers 25 (FIG. 2) asstand-alone software, as part of software 34, or as software provided asa service by server 52 via a secure web implementation over publicnetwork 50. Upon a processor 76 executing the program from memory 78 ofthe clinician computer 25, as one function among others, the processor76 after receiving a query for a medical use case and/or question,searches memory 78, computer readable medium 40, and/or server 52 forall structured collection procedures 70 a-d, which matches the submittedquery in step 302. For example, the processor 76 may read the medicaluse case parameter 220 of each available structured collectionprocedures 70 a-d and using a conventional search algorithm (e.g., list,tree, heuristics, etc.), provide on a display 82 a selection choice forthose structured collection procedure matching the query in step 304 inone embodiment.

In one embodiment, the list displayed can reflect, for example, thestructured collection procedures 70 a, 70 b, 70 c, and 70 d availablefor use from the server 52. In still another embodiment, the list ofselection choices displayed can be dynamically created based on a typeof medical use case the clinician 14 wishes to investigate. For example,prior to step 302, a list of selectable medical use cases can bedisplayed on the display 82 by the processor 76. In such an embodiment,the clinician 14, using the user interface device(s) 86 may selectedfrom among the displayed medical use cases, for example, the medical usecase “Determining meal effect on patient's therapy.” After the clinicianmakes such a selection, which the processor 76 receives as input fromthe user interface device(s) 86, the processor 76 after using decisionlogic (e.g., if . . . then) provided by the software 34 would thendisplay in step 304, for example, structured collection procedure 70 b(e.g., a structured collection procedure to determine a more accurateinsulin-to-carbohydrate ratio) and 70 c (e.g., a structured collectionprocedure to determine bolus timing in regards to meal start), and notstructured collection procedures 70 a and 70 d, which are structuredcollection procedures unrelated to the medical use case. Likewise, a“show all structured collection procedures” could also be a choice amongthe displayed medical use cases, in which the complete list of availablestructured collection procedures would then be displayed in step 304. Inanother embodiment, step 302 may be skipped and the processor 76 in step304 can just provide a display of the structured collection procedures70 a-d available in memory 78 of the clinician computer 25.

In step 306, a clinician using the user interface devices 86 can selecta structured collection procedure 70 on the clinician computer 25 fordiagnostic or therapy support. For example, the selecting process caninclude choosing from the list displayed in step 304, which provided oneor more structured collection procedures. After the clinician makes sucha selection in step 306, which the processor 76 receives as input fromthe user interface device(s) 62, the processor 76 of the cliniciancomputer 25 retrieves automatically from an electronic component, e.g.,computer memory 78, server 52, or computer readable medium 40, anddisplays the selected structured collection procedure 70 on display 82for viewing.

It is to be appreciated that each structured collection procedures 70 a,70 b, 70 c, and 70 d is based on a medical use case and has parametersdefining entry criteria 226, a schedule of collection events 222,adherence criteria 224, and exit criteria 228. As mentioned above, theentry criteria 226 establish the conditions needed to be met prior toobtaining biomarker data from the patient. Each collection event 237 ofthe schedule of collection events 222 comprises a performance time,patient guidance to perform the event, patient actions, a request forinformation from the patient, a request for collection of at least onetype of biomarker data from the patient, and combinations thereof. Theadherence criteria 224 is used to qualitatively assess whether acollection event 237 performed according to the schedule of collectionevents 222 provided data which is acceptable to addressing the medicaluse case upon which the structured collection procedure 70 is based.Additionally, as mentioned above, the exit criteria 228 establish theconditions needed to be met prior to exiting the structured collectionprocedure 70.

In step 310, after the processor 76 displays the selected structuredcollection procedure 70, the clinician 14, to meet the needs of thepatient 12 and/or interests of the clinician, may adjust any one of theparameters 222, 224, 226, and 228 which are also displayed on thedisplay 82. Safe guards may be implemented to ensure that only theclinician 14 can modify such parameters and/or run the software 34, suchas via password protection. The processor 76 receives any such changesto the parameters 222, 224, 226, and 228 as input via user interfacedevices 86 and saves the revised structured collection procedure 70 inmemory 78. Next, in step 312, the selected structured collectionprocedure 70 is prescribed on the clinician computer 25 to the patient12 by the clinician 14, wherein the processor 76 of the cliniciancomputer 25 provides as output the selected structured collectionprocedure 70 to the patient 12 to perform. For example, in step 314, theprescribed structured collection procedure 70 is implementedelectronically on a processor based device, such as collection device24, or any of the other above described devices 18, 28, and 36 (FIG. 1),as part of the software 34 or in other embodiment, portions thereof aspart of paper tool 38.

In one embodiment, the prescribed structured collection procedure 70 maybe implemented from the clinician computer 25 (FIG. 2) to the collectiondevice 24 via communication link 72, via the public network 50 through awebpage and/or made available for downloading on server 52. In stillother embodiments, the prescribed structured collection procedure 70 canbe provided through the computer readable medium 40 and loaded by one ofthe devices 18, 24, 28, and 36, downloaded from another one of thedevices 18, 24, 25, 26, 28, and 36, or downloaded via cell phone ortelephone connection from server 52. Notice that anew/updated/prescribed structured collection procedure 70 available foruse on the devices 18, 24, 25, 26, 28 and 36 may be provided in anystandard fashion, such for via postal letters/cards, email, textmessaging, tweets, and the likes. Reference hereafter is also made toFIG. 7B to further describe the features of the present invention.

Customizing a Structured Collection Procedure

FIG. 7B conceptually illustrates one example of a pre-defined structuredcollection procedure 70, which has a defined medical use case parameter220 indicating that the procedure is helpful for medical use cases orquestions which need to know the trends in blood glucose (bG) levels ofa patient and/or the relationships between blood glucose values and timeof day, meal size, and energy level. As mentioned above previously, theuse case parameter 220 can be used as an identity tag in which theprocessor 102 may locate the associated structured collection procedure70 in response to a search query, such as, for entered use case orquestion. For example, the search query can be entered into thecollection device 24 via the user interface 146 and/or received from theclinician computer 25. Such a search query may result from a desire toknow which uses case can be addressed by the structured collectionprocedures 70 currently available on the collection device 24, or toknow which structured collection procedure 70 would be useful to addressa particular use case or question. Therefore, the use case parameter 220in one embodiment permits a structured collection procedure 70 to beautomatically chosen by the processor 102 from a plurality of structuredcollection procedures 70 a-d, such as provided in memory 110, memory 78,computer readable medium 40, and/or server 52 based on a selection, suchas from a displayed list on the display 108 provided by the processor102, or from input received by the processor 102 from the user interfaceof a defined medical question. In other embodiments, the use caseparameter 220 may also indicate the structured collection procedure 70is also useful for showing relationships between bG level values andtime of day, meal size, and/or energy level.

In one embodiment, the pre-defined parameters of the structuredcollection procedure 70 can be displayed for modification/customizationby the processor 102 of the collection device 24 on the display 108and/or by the processor 76 of the clinician computer 25 on the display82 by an authorized user. Such an authorized user may be identified, forexample, on the collection device 24 and/or the clinician computer 25 bya password entered via the user interface device 146, 86, respectively.In such an embodiment, the pre-define parameters of structuredcollection procedure 70 can be displayed on the display 108, 82 in whichcustomizable parameters can provide editable or selectable variables viadrop-down boxes with various selection choices, radio buttons, checkboxes, formatted fields requesting a specific type of information(mm-dd-yyyy, number, letter, etc.), text boxes to enter messages to bedisplayed, and the likes. The structured collection procedure 70 can bedisplayed for editing in tabular format (as illustrated) in oneembodiment or in a sequential manner listing one parameter at a time ina scroll-through fashion in another embodiment. In still anotherembodiment, structured collection procedures can be provided whichcannot be modified.

As shown by FIG. 7B, the structured collection procedure 70 may furthercomprise parameters defining one or more criteria setting the conditionsneeding to be met by the patient 12 to start of the structuredcollection procedure, i.e., entry criterion(s) 226, to end thestructured collection procedure i.e., exit criterion(s) 228, andcombinations thereof. In one embodiment, the processor 102 of thecollection device 24 uses the one or more criteria to automaticallystart, evaluate, and end the structured collection procedure 70 if thecondition(s) defined by the structured collection procedure are met. Instill another embodiment, adherence criterion(s) 224, which are theconditions needing to be met in order for the collected datum/data to beaccepted, can also be provided in the structured collection procedure70.

As also shown in FIG. 7B, the structured collection procedure 70 furthercomprise parameters defining one or more collection events 237 whichtogether form the schedule of collection events 222. Each of thecollection events 237 comprises one or more requests 240, e.g., for ameasurement from the measurement engine 138 of a biomarker value for asample provided to the biosensor 140, and/or for information to beentered by the patient via the user interface 146 such as in response toa question presented by the processor 102 on the display 108. In theillustrated embodiment, the requests 240 are for a bG measurement, ameal size indication (S, M, or L), and an energy level indication (1, 2,3, 4, 5), in which 1 is lowest and 5 is highest. Other such requests 240can include indicating whether the patient exercised, indicating aparticular food that was consumed, indicating which medicine wasadministered, indicating dosage of the medicine administered, and thelike may also be provided in other structured collection procedures 70.In the illustrated embodiment, the collection events can be customizedby selecting which request 240 the processor 102 should perform via ayes/no selection box.

The structured collection procedure 70 may also include guidance 230 andtiming or performance time 238 associated with each of the collectionevents 237 as well as with each of the entry, exit, and adherencecriterion/criteria 226, 228, and 224. Such guidance 230 is provided bythe processor 102 to the display 108 upon the occurrence of theassociated collection event 237 or other parameters. For example, acollection event 237 for a bG measurement before breakfast may also havea request 240 for an indication of the energy level of the patient.Therefore, in this example, the associated guidance 230 which states,“Please indicate energy level” is provided on the display 108 by theprocessor 102. It is to be appreciated that the guidance 230 is a textbox, field, area, which enables for information to be provided to thepatient to help the patient in performance of the structured collectionprocedure 70. In this example, selection of a number from 1 to 5 may bemade via press of one of the buttons 147, 149 or via the touch screeninterface if provided by display 108 as a data entry for such a request240, which is then stored by the processor 102 in memory 110 of thecollection device 24 as part of a data file 145 (FIG. 4) for thestructured collection procedure 70.

The timing parameter 238 of the structured collection procedure 70 isused to specify for any one of the associated collection event 237, theentry, exit, and adherence criterion/criteria 226, 228, 224, either aspecific date and/or time (mm-dd-yyyy, hh:mm), or a period (n) after apreceding collection event in which to perform the associated collectionevent. The periods n₁, n₂, n₃ in the illustrated embodiment for therespective collection events 237 indicate hours, but in otherembodiments can be indicated in minutes or seconds. In anotherembodiment, the timing or performance time parameter 238 for anassociated collection event 237 and for the entry, exit, and adherencecriterion/criteria 226, 228, 224 can be modified by another collectionevent and/or by the criterion/criteria.

For example, in the illustrate embodiment, the entry criterion 226 ismodified by the adherence criterion 224 by adding a day if the guidance230 provided in the form of a question “Are you willing to conduct atest over 3 consecutive days?” is not affirmed by the patient 12 e.g.,via a “No” selection provided on the collection device 24. In thisillustrated example, the “Affirms guidance” may be a drop down selectionprovided in a combo box for customizing the adherence criterion 224 ofthe associated collection event 237, which when selected causes theprocessor 102 to wait for the accepted/not accepted input (e.g., viabuttons 147, 149) before executing the remaining logic (“if not add 1day to timing”) of the adherence criterion 224. Still further in thisexample, the processor 102 in accordance with the logic provided in theadherence criterion 224 associated with the exit criterion 228, can setthe timing or performance time parameter 238 of the exit criterion 228to the date (mm-dd-yyyy) that is 3 days after completing the entrycriterion 226. It is to be appreciated that the various possiblecombinations of logic statements which may be performed by thestructured collection procedure 70 can be pre-defined and selected by adrop down box in order to be customized in one embodiment, and/or logicstatements can be built in another embodiment.

Further details of the use of the entry, exit, and adherencecriterion/criteria 226, 228, 224, respectively, are provided by U.S.patent application Ser. No. 12/643,338 filed Dec. 21, 2009 entitled“Contextualized biomarker data for diabetes diagnostics and therapysupport,” and assigned to Roche Diagnostics Operations, Inc., which ishereby incorporated by reference.

The structured collection procedure 70 can also includes in oneembodiment an options parameter 232 associated with each of thecollection events 237 as well as with each of the entry, exit, andadherence criterion/criteria 226, 228, 224. The options parameter 232can have a customizable value(s) to govern whether the data and/orresults of the associated collection event 237 or any of the otherparameters e.g., entry, exit, and adherence criterion/criteria 226, 228,224, in the structured collection procedure 70 meets a particularcondition such that still further processing may be carried out by theprocessor 102 if such a condition(s) is meet. For example, such optionscan be to have the processor 102 automatically send a message to theclinician indicating that the patient has started the structuredcollection procedure 70 via satisfying the entry criterion 226, or toprovide a message to the patient and/or the clinician if the patientfails a collection event 237 by not satisfying an adherence criterion,or to provide a message to the clinician when the patient completes thestructured collection procedure 70 when the exit criterion is satisfied,or combinations thereof. For example, such an options parameter 232 canhave a global list of such actions which is selected on the display 108,for example, by a selected value from a range of values associated witheach option. For example, the options for each parameter can becustomized via selecting from a drop down box having option choices(e.g., 1, 2, 3, 4, 5, . . . , A, B, C, etc.). In the illustratedembodiment depicted by FIG. 7B, for example, having Option 1 provided inthe options parameter 232 of the collection procedure 70 will cause theprocessor 102 to provide a message to the clinician if the patient failsthe associated “Before Breakfast” collection event 237, i.e., by notsatisfying the adherence criterion 224. In still another embodiment,Option 2 can be a message which provides the patient positivereinforcement for successfully completing a collection event 237 e.g.,“Good Job!,” which the processor 102 automatically displays to thepatient 12 on the display 106 of the collection device 24 when theassociated adherence criterion 224 is satisfied Likewise, in stillanother embodiment, Option 3 can be a message which provides negativereinforcement if the collection event 237 is not successfully completed,which the processor 102 automatically displays to the patient 12 on thedisplay 106 of the collection device 24 when the associated adherencecriterion 224 is not satisfied.

In another embodiment, the structured collection procedure 70 can alsoinclude a view flag parameter 239 associated with each of the collectionevents 222 as well as with each of the entry, exit, and adherencecriterion/criteria 226, 228, 224 and checks 264 (if viewable data isgenerated and record by the processor 102 in an associated data record152 of the data file 145). It is to be appreciated that most clinicians14 rely on data to perform physiological assessment, therapy selection,therapy optimization, and therapy monitoring. Such data typically is acombination of clinical laboratory data, ambulatory or self-monitoreddata as well as findings discovered or measured by the clinician 14during a clinical visit by the patient 12. The clinician's reliance onsuch data is based on the assumptions of data context,representativeness, completeness, accuracy, and precision.

Self-monitored data takes a prominent roll in the management of peoplewith a chronic disease, such as diabetes. As clinical lab values such asHbA1c provide a metric for the ‘average self care’ provided over aminimum of a four week process, the metric does not provide informationwhich is actionable by the person with diabetes, nor does the HbA1cprovide information as to why the value is either good or bad.Spot/continuous bG monitoring coupled with a well documented log book ofmeals, exercise, stressors, and therapeutic administrations oftenprovide the best source of information to the clinician 14.

It is to be appreciated that prior to the present invention, thetypically manner of providing such self-monitored data by patients withdiabetes to their clinicians is in the form of ‘casual’ data. Casualdata is data collected under varying circumstances and for variousreasons. Casual data presents itself as capricious values to theclinician—primarily due to lack of defined processes leading up to themeasured values. Casual data requires the clinician to impute the datumcircumstances from time of day. For example, the clinician would ascribethe first datum of the day as a fasting sample, providing it was in themorning. Some improvements have been made in the art, such as forexample, permitting the patient 12 to mark such casual data—eithermanually with ‘fasting’, ‘pre-dinner’, ‘post-dinner’ markers and thelike, or automatically by a timestamp. By doing so, the clinician nolonger had to impute the datum circumstances. However, before thevarious embodiments of present invention, the coupling of what theclinician required for differential diagnosis to what the patient 12provided at time of service had not been addressed successfully in theart. Historically, the clinician 14 was required to tease patterns fromthe data, and speculate on causal agents e.g., by looking at a table ofdata, and trying to identify whether each interval within a day isadequately managed.

To address the above noted issues, embodiments of the present inventionprovide further capabilities to the structured collection procedure 70described previously above which leverage the advantages presented bysuch a procedure. Some of the noted advantages of the structuredcollection procedure 70, and not to be limited thereto, are that: thesteps necessary for the patient to produce reliable results are enforcedwithin the system, which changes the identification of ‘circumstances’of data points to ‘context’ of a data point; a method is provided whichhelps to ensure that an adequate quantity of contextualized data pointsto provide a representative data set are collected, which changes thedata from casual—one which the physician must guess—to actionable; andpermits therapy optimizations to be accomplished at the patient's homewith little clinician oversight, and minimal additional risk to thepatient.

It is to be appreciated that the structured collection procedures 70 canbe further classified into two general classes—assessments andoptimizations. Assessment procedures (mentioned previously above in anearly section) generally are used to collect data that will later beassessed, analyzed, and actioned on by the clinician 14. Optimizationprocedures are used to adjust therapy parameters and the like, andfunction by collecting repeated samples under known conditions, thenmaking adjustments to the parameters until an exit criteria is met. TheAccu-Chek 360 View form, also mentioned previously above, is an exampleof an assessment procedure, which acquires three days of seven datapoints per day. The clinician 14 can then utilize such data from theform in order to assess how well the patient 12 is self managing theirdiabetes based on therapy prescriptions determined by the clinician.

It is further to be appreciated that through clinical trials, which usedthe Accu-Chek 360 View form, it was discovered that although the datashowed a betterment of data values occurring on day 3 versus day 1,repeated measures of the same patients with the same tests showedregular regression after this day 3 trended toward better indications ofself management. In other words, the patients were getting betterthrough the use of the form, then going back to their old ways of selfmanagement. Accordingly, the data was not representative of the normalbehavior of the patient.

Therefore, to address the above mentioned issue, the view flag parameter239 associated with each of the collection events 222 as well as witheach of the entry, exit, and adherence criterion/criteria 226, 228, 224and checks 264 provided in an embodiment of the structured collectionprocedure 70 provides the clinician 14 with the opportunity to blinddesired ones of the data point values as well as the associatedcontextualized data (e.g., the contextualized biomarker data) from thepatient 12, i.e., the associated ones of the data records 152 in thedata file 145. In this manner, the patient 12 would not have anyinformation by which to adjust their behavior, while maintaining thesafety of the user. Such an embodiment should lead to better, morerepresentative data befitting of the patient's real lifestyle.

In one embodiment, the view flag parameter 239 has a viewable value anda non-viewable value, e.g., binary, character, etc. The view flagparameter 239 in the structured collection procedure 70 governs whetherthe data and results of the associated collection event 237 or any ofthe other parameters e.g., entry, exit, and adherence criterion/criteria226, 228, 224, and checks 264, in the structured collection procedure 70can by displayed on the display 108 by the processor 102. If theviewable value (e.g., “Yes”) is set for the view flag parameter 239 inthe structured collection procedure 70, then the data and results of theassociated collection event 237 (or other parameters) may be displayedby the processor 102 in the display 108 and if the non-viewable value(e.g. “No” or <null>), then such data and results cannot be displayed bythe processor 102 in the display 108. In one embodiment, the setting ofeach of the view flag parameters 239 is predetermined by the structuredcollection procedure 70 e.g., when authored by a third party, and whichin another embodiment may be modified (edited) at the discretion of theclinician 14. For example, the clinician 14 can modify/edit any of thestructured collection procedure 70 on the clinician computer 25, and/oron the collection device 24 e.g., by entering a password designating theclinician 14 as an authorized user having editing rights. In oneembodiment, the clinician 14 is presented e.g., on clinician computer 25and/or on collection device 24, with a selection menu showing each ofthe collection events and/or the documenting and interrelatingconditions that (or will) surround the associated biomarkermeasurement(s) for contextualization, e.g., a listing of biomarkerevents listed by pre-prandial measurements events, post prandialmeasurement events, before bed events, etc., which permits theauthorized user to select either the viewable value or non-viewablevalue for the view flag in order to designate which ones of thecollection events 237 are either viewable or non-viewable. It is to beappreciated that in other embodiments, instead of listing eachparticular collection event 237 (and/or their associated context) in thestructured collection procedure 70, other selection menus havingglobally selectable view parameter values based on the contextualizationtype of the collection event e.g., all collection events 237 beforeand/or after exercising, all collection events 237 before and/or after ameal type and size, all collection events 237 before and/or after anamount of sleep, all collection events 237 before and/or after aspecific time, date-time, etc., can also be provided.

It is to be appreciated that the patient 12 is still provided with thenecessary data for managing their condition. For example, in the case ofa patient with diabetes, key data points used to adjust insulin dosageswould, by default, always be presented to the patient 12 on the display108 by the processor 102. By default, it is meant that special caseconditions—those requiring immediate action by the user—such ashypoglycemic events (e.g., bG values below 70 mg/dl), or severehypoglycemic events (e.g., bG values below 56 mg/dl), or hyperglycemicevents (e.g., bG values greater than 450 mg/dl), would be presented tothe patient on the display 108 by the processor regardless of the stateof the view flag parameter 239.

In another embodiment, the view flag parameter 239 has value (e.g.,“AC”) which causes the processor 102 to check whether the data valuecollected according to the event 237 meets the adherence criteria 224,and if so will designated the data associated with the event 237 in thedata file 145 as viewable. In still another embodiment, the view flagparameter 239 has value (e.g., “nAC”) which causes the processor 102 tocheck, and designated in the data file 145 as viewable, the data valuecollected according to an event 237 which does not meet the adherencecriteria 224.

It is to be appreciated that in one embodiment, not only during theexecution of the structured collection procedure 70 would such flaggeddata be masked from the patient 12, but also upon completion of theprocedure such flagged data would also be masked from review by thepatient, i.e., neither via the display 108 nor on any computing systemconnected to the device e.g., patient computer 18 (such as via Smart Pixdevice, Accu-Chek 360 end user software, and the likes), without properauthorization. Typically, the clinician 14 will only have the properauthorization e.g., via a password and/or encryption, in order to gainaccess to such data in the data file 145. As passwording and/orencrypting a data file or portions thereof is well known to thoseskilled in the related art, for brevity no further discussion isprovided.

In another embodiment, after completion of the structured collectionprocedure 70, the patient may, at the discretion of the clinician 14 (orauthor of the procedure), have data visibility. In another embodiment,any data created as part of a structured collection procedure 70 isprevented from deletion by the end user, thereby stopping the patient 12from selectively presenting data to the clinician 14. An example in thecontext of patient 12 being diabetic is provided hereafter to furtherillustrate the above mentioned features of having a collection device 24running the above mentioned structured collection procedure 70 accordingto the present invention.

A typical patient with Type 2 diabetes may measure his/her blood glucoseonce per day after waking up in the morning. At a routine office visit,the patient's HbA1C result is found to be elevated. The clinicianrecommends that the person goes through three days of intensifiedglucose monitoring, and selects the structured collection procedurewhich is useful for this purpose. The structured collection procedure 70is then customized as discussed above such that during these three daysthe collection events 237 are defined with a number bG measurementrequests 240 such that the patient can be requested by the processor 102to measure his/her blood glucose before and two hours (e.g., n₁=2) afterbreakfast, before and two hours (n₂=2) after lunch, before and two hours(n₃=2) after supper, and at bedtime. Additionally, the patient 12 can berequested via other associated requests 240 for each collection event237 to provide an assessment of the relative size of the ingested mealsat the appropriate times as well as an indication how he/she feels withregard to energy level. In the illustrate embodiment of FIG. 7B, theprocessor 102 can request the indication of energy level with eachcollection event 237 and the assessment of the relative size of theingested meals every other collection event 237 (i.e., after the meal).Furthermore, the clinician has provided a condition via adherencecriterion 224 of having to perform the meal assessment within ±30minutes of period (n) of the associated collection event 237 in orderfor such information to be useful in the assessment. Such information isuseful to contextualize the collected data and for the analysisperformed on the collected data.

Additionally, the clinician 14 would like to be notified when thepatient has failed to complete the “before breakfast” collection event237. Therefore, to facilitate the notification option, the clinician 14customizes the structured collection procedure 70 by set the optionsparameter 232 associated with the “before breakfast” collection event,via a drop down box to “Send a message to the clinician if adherencecriterion fails.” All other collection events 237 have their associatedoptions parameter 232 default to indicate that the processor 102 is notto take any additional action with regards to the options parameter.

Furthermore, since the clinician 14 would like to assess the patient'susual behavior to draw conclusions about the cause of the elevated HbA1Cvalue, the clinician 14 does not want the patient 12 to change his/herbehavior over these three days. Therefore, the collection device 24(e.g., blood glucose meter 26) should only display test results that aretaken according to the patient's usual testing habit. In this example,where the patient usually only measures directly after waking up, thecollection device 24 should only display a test result taken accordingto the structured collection procedure 70 when the test time is closeenough to the usual test time of the patient and no other test that hasbeen taken on the current day could be interpreted as wake-up timemeasurement. Furthermore, the clinician 14 decides that positive andnegative reinforcement may be needed at particular times.

To make the above assessment, the clinician 14 asks the patient 12 abouthis/her usual testing habit. In this example, the clinician 14 thencustomizes the structured collection procedure 70 by marking the viewflag parameter 239 of the “Before breakfast” collection event 237 toindicated that such a result is okay for the processor 102 to display onthe display 108, i.e., View flag 239 set to “Y” as depicted by FIG. 7B.However, for this particular example, the clinician 14 decided to havethe next two collection events 237, i.e., “n₁ Hours After Breakfast” and“Before Lunch” as well as the “Before Dinner” and “Before Bed”collection events 237 to have their associated view flag parameterdefaulted to indicate that they are not to be displayed by the processor102, i.e., view flag 239 set to “N” as also depicted by FIG. 7B.Additionally, the clinician 14 further wants the “n₂ Hours after Lunch”collection event 237 to be conditionally viewable (i.e., displayable onthe display 106 by the processor 102) only if the adherence criteria 224associated therewith is satisfied i.e., the data value collected within±30 minutes of n₂ event 237 and to provide a message for reasons ofpositive reinforcement in this example. To do this, the clinician 14customized the collection procedure 70 by setting the view flag 239associated with the “n₂ Hours after Lunch” collection event 237 to beingconditionally viewable, i.e., view flag 239 set to “AC” and to providethe Option 2 message (e.g., a positive reinforcement message) asdepicted by FIG. 7B. Finally, the collection procedure 70 was furthercustomized by the clinician 14 to permit the data value collected forthe “n₃ Hours after Dinner” collection event 237 to be displayable bythe processor 102 only if the adherence criteria 224 associatedtherewith i.e., “±30 minutes of n₃” is not satisfied via setting theassociated view flag 239 to “nAC” and to provide the Option 3 message(e.g., the negative reinforcement message) as depicted by FIG. 7B inthis example. In still other embodiments, other combinations of messagesand collected data that is viewable, not viewable, or beingconditionally viewable can be provided in various collection procedures70, either pre-defined and/or customized by the clinician 14 as desiredvia simply setting one of the above mentioned parameters of the options232 and view flag 239 in the collection procedure 70 as described above.It is to be appreciated, and in still another embodiment, the patient 12can choose at any time to take a measurement outside of the structuredcollection procedure 70 in which the results of such a measurement willbe displayed by the processor 102 on the display 108 as usual.

It is to be appreciated that the above described features andarrangements illustrated embodiment of FIG. 7B, provides a simply andconvenient interface and method for customizing a structured collectionprocedure, such as for parameter adjustments carried out in step 310 ofmethod 300 previously discussed above in reference to FIG. 7A.

Implementing and Performing a Structured Collection Procedure

FIG. 8A shows a flowchart of the method for implementing and performinga structured collection procedure 70 to obtain contextualized biomarkerdata from a patient 12 according to an embodiment of the invention. Itis to be appreciated that a number of structured collection procedures70 a-d (FIG. 2) prescribed in step 312 and implement in step 314 (FIG.7A) may be stored in memory 110 (FIG. 3) of the collection device 24 andselected for execution at any desired time. For example, upon pressing acertain combination of the buttons 147, 149, the patient can select adesired structured collection procedures 70 a-c and the date when tostart a structured collection, i.e., a set mode function. For example, adate range to choose from may be to begin the testing tomorrow and endat today +90 days, which the processor 102 can also recorded in the datafile 145 (FIG. 4) as part of the setup data 163. In such animplementation, the processor 102 as instructed by the software 34 readsthe setup data 163 for the selected structured collection procedure 70and indicates on the display 108 that the collection device 24 is in astructured testing mode, for example, from one day before the chosenstart date until the end of the structured collection procedure.

It should be appreciated that multiple structured collection procedures70 a-d can be executed sequentially or simultaneously at any given time.However, in one embodiment, the software 34 permits the user only toschedule another structured collection procedure 70 if the start date islater than the end date of the current structured collection procedure70 being executed. The software 34 also permits the user to override ascheduled date for a structured collection procedure 70. If a structuredcollection procedure 70 is scheduled and the user enters the set modefunction again, the software 34 causes the processor 102 to display thescheduled date on the display 108 as the default date; if the user exitsthe set mode without modifying the date, the previously scheduled datestays active. If a structured collection procedure 70 has started, thesoftware 34 permits the user to enter the set mode and cause theprocessor 102 to cancel the current structured collection procedure 70.Upon cancellation, in one embodiment, the software 34 causes theprocessor 102 to de-tag (e.g., null the unique identifiers 167) the datarecords 152 in the data file 145 for the data collected for thecancelled structured collection procedure 70.

Upon reaching the procedure start in step 316 (FIG. 8A), the processor102 evaluates the whether entry criterion(s) 226 is met in step 318 tobegin the structured collection procedure 70 selected to obtainbiomarker data to address a predefined use case or question (e.g., usecase parameter 220). In step 320, the processor 102 specifies requests240 according to their associated timing 238 for each collection event237 in the schedule of collection events 222 for the structuredcollection procedure 70. It is to be appreciated that the schedule ofcollection events 222 provides a sampling plan for biomarker datacollection that is performed by the processor 102 to obtain biomarkerdata in a predefined context. In performing the schedule of collectionevents 222 in step 320, the software 34 causes the processor 102 toassign a unique identifier (e.g. incremental count) 167 in a date record152 which corresponds to each collection event 237 in the structuredcollection procedure 70. Optionally, each criterion 226, 228, 224 mayalso be provide with a date time stamp 169 to indicate when suchcriterion was satisfied, if desired.

Adherence criterion 224 is then applied to the input received (e.g.,biomarker data or information) in response to a request 240 to determinewhether the input received meets the adherence criterion 224. When astructured collection procedure 70 has started, all data collectedaccording to requests 240 in the structured collection procedure 70 andwhich satisfy the adherence criterion 224, if required in step 322, arethen assigned (tagged) in the data file 145 by the processor 102 withthe unique identifier 167 in step 324. It is to be appreciated that theunique identified also serves to associates the collected data e.g.,data values 256 with their collection event 237, the request 240, and adate-time stamp 169 to indicate when the collection in response to therequest 240 was received by the processor 102. While a structuredcollection procedure 70 is being executed, in one embodiment thesoftware 34 permits the user to perform a measurement on the collectiondevice 24 at any time without interfering with the episode and be ableto view the measurement results on the display 108 (i.e., anotherspecial case condition).

In one embodiment, the software 34 permits reminders for biomarkermeasurements to be ‘snoozed’ as mentioned above for a period, such asfor example, 15 minutes and up to a number of times, for non-criticalmeasurements. In another embodiment, biomarker measurements or dataentries that are performed close enough in time to a request 240 in step320 are designed as valid measurements or data entry for the request 240by the software 34. As such, the processor 102 will tag the associateddata record 152 for the collection event 237 with the unique identifier167 for such a biomarker measurement or data entry accordingly. In thecase of biomarker measurements, if the measurement is accepted as validfor the request 240, the software 34 causes the processor 102 to promptthe user to input additional information if needed by the structuredcollection procedure 70 to provide context 252 for data resulting fromthe request 240. Such additional input, may include, for example, arating of energy level from 1 to 5, where 1 is low and 5 is high; mealsize from 1 to 5 where 1 is small and 5 is large, and exercises from yesor 1 to mean over 30 minutes, and no or 2 to mean less than 30 minutes.Such additional information or contextual information 156 when inputtedvia the user interface 146 is stored by the processor 102 in the datafile 145 associated with the unique identifier 167 for the data eventrequest 240 requiring the additional information also in step 324.

In one embodiment, biomarker measurements determined by the processor102 as not being close enough in time to the data event request 240defined by the structured collection procedure 70 will not be taggedwith a unique identifier 167 in the data file 145 by the processor 102.Such is illustrated in the shown data file 145 with request 240 d anddata values 256 d not being associated with a unique identifier 167e.g., <null>. An example of a definition of ‘close enough in time to thecollection procedure’ as instructed by the structured collectionprocedure 70 and/or software 34 to cause the processor 102 to make sucha determination may be defined as being relative to a prescheduled timeor a snoozed time. For example, for pre-prandial measurements up to 15minutes in anticipation is acceptable; for post-prandial measurements,up to 10 minutes in anticipation is acceptable; and for bedtimemeasurements, up to 15 minutes in anticipation is acceptable. Otherdefinitions may be provided in other structured collection procedures 70and/or software 34.

In step 326, the processor 102 then evaluates whether the exit criterion228 for the selected structured collection procedure 70 is satisfied. Ifnot, then the processor 102 continues with performance the schedule ofcollection events 222 until the exit criterion 228 is satisfied. Uponsatisfying the exit criterion 228, the structured collection procedure70 ends in step 328. In one embodiment, the structured collectionprocedure 70 may also end if in step 318, the entry criterion 226 isalso not met.

In some embodiments, the structured collection procedure 70 can beconfigured for performance as a paper tool 38; diabetes software 34integrated into a collection device 24 such as a blood glucose meter 26;diabetes software 34 integrated into the computing device 36, such as apersonal digital assistant, handheld computer, or mobile phone; diabetessoftware 34 integrated into a device reader 22 coupled to a computer;diabetes software 34 operating on a computers 18 and/or 25, such as apersonal computer; and diabetes software 34 accessed remotely throughthe internet, such as from a server 52. When diabetes software 34 isintegrated into a collection device 24 or a computing device 36, thediabetes software 34 can prompt the patient to record diary informationsuch as meal characteristics, exercise, and energy levels. The diabetessoftware 34 can also prompt the patient to obtain biomarker values sucha blood glucose values.

GUI Interface Providing a Selectable Structured Collection Procedure

FIG. 8B shows a method of implementing the structured collectionprocedure via a graphical user interface provided on a collection device24, which when executed on the collection device, cause the processor102 to perform the following steps. Upon pressing a certain combinationof the buttons 147, 149, the patient 12 can scroll to the structuredcollection procedure 70 available for selection in a list 329 providedby the processor 102 on the display 108 of the collection device 24 instep 330. If desiring to start the structured collection procedure, thepatient 12, for example, selects via pressing an OK button 151 in step332, the desired structured collection procedure 70. In this example,the entry criteria 226 (FIG. 6) of the structured collection procedure70 provides information in step 334 which the processor 102 displays tothe user on the display 108. After reading the displayed information,the user presses any button in step 336 in which the next procedure inthe entry criteria 226 is performed by the processor 102. In thisillustrated example, as part of the entry criteria 226, a question isthen asked in step 338 by the processor 102. If the patient 12 is stilldesirous of starting the structured collection procedure, the patient 12selects the OK button 151 in step 340; otherwise, any other press viabutton 147, 149 will cause the processor to go back to the list 329,thereby stopping the set-up procedure for the structured collectionprocedure 70.

After the patient 12 presses the OK button 151, the processor 102 instep 342 will provide on the display 108 an alarm clock 343 for settingthe time to begin the selected structured collection procedure 70. It isto be appreciated that all the required collection events 237 forbiomarker sampling, patient information, etc., is automatically scheduleby the processor 102 in accordance with the schedule of collectionevents 222 for the structured collection procedure 70 in which timing,values, questions, viewable fields, viewable data, etc., therein mayhave been adjusted by the clinician 14 as discussed previously above inreference to FIGS. 7A and 7B. Therefore, other than entering the starttime as permitted by the entry criteria 226, no other parameteradjustments in the structured collection procedure 70 is required by thepatient 12 (or permitted in one embodiment).

In the illustrated embodiment, the patient in step 344 can adjust thestart time of the structured collection procedure for the next day,e.g., Day 1, via buttons 147, 149. Upon confirming the start time instep 346 via pressing the OK button 151, the start time is recorded inmemory 110 as part of the setup data 163 in the data file 145 (FIG. 4)for the structured collection procedure 70 by the processor 102. Theprocessor 102 then displays the selection list 329 on the display 108 instep 348, thereby completing the set-up procedure, which satisfies theentry criterion 226, and indicates on the display 108 that thecollection device 24 is in a structured testing mode 349.

It should be appreciated that in one embodiment multiple structuredcollection procedures can be executed sequentially or simultaneously atany given time, and hence in one embodiment the mode 349 provided on thedisplay 108 will indicated which structured testing is being performed.However, in one preferred embodiment, the software 34 does not permitsthe user to schedule another structured collection procedure, unless thestart date is later than the end date of the current structuredcollection procedure being executed via the user interface 146. It is tobe appreciated that processor 102 may re-schedule the followingstructured collection procedures automatically if the current structuredcollection procedure is still running due to the exit criteria 228 notbeing met. The software 34 in another embodiment may also permit theuser to override a scheduled date for a structured collection procedure.If a structured collection procedure is scheduled and the user entersthe set mode function again, the software 34 causes the processor 102 todisplay the scheduled date on the display 108 as the default date; ifthe user exits the set mode without modifying the date, the previouslyscheduled date stays active. If a structured collection procedure hasstarted, the software 34 permits the user to enter the set mode andcause the processor 102 to cancel the current structured collectionprocedure, if desired.

In step 350, an alarm condition 351 can be provided by the processor 102the next day (as indicated by the symbol Day1) as was set in theabove-mentioned procedure the previous day (as indicted by the symbolStart Up). Upon the user selecting any button 147, 149, 151 in step 352,the processor 102 as instructed by schedule of collection events 222,provides a first scheduled collection event 237 which is information 353to be displayed on display 108 in step 354, which the patient 12acknowledges with any button 147, 149, 151 being pressed in step 356.Next in step 358, the processor 102 is instructed by the schedule ofcollection events 222 to execute a second scheduled event, which is todisplay on the display 108 a question 359 for the patient, which thepatient 12 acknowledges with any button 147, 149, 151 pressed in step360. In the illustrated embodiment, the patient in step 362 indicatesthe start time of breakfast in minutes from the wake up alarm 351previously acknowledged in step 352. Upon confirming the meal start timein step 364 to the processor 102, via pressing the OK button 151, themeal start time is recorded in memory 110. For example, the meal starttime is recorded in the data file 144 in the associated data record 152as data for the collection event 237 by the processor 102. Additionally,in step 366, the processor 102 displays to the patient 12 theinformation regarding the timing for the next schedule event as areminder. In step 368, upon reaching the next scheduled event indictedby the schedule of collection events 222, the processor 102 provides arequest 240 on the display 108 for the patient to take a measurement,e.g., a blood glucose measurement. Additionally, in step 370, theprocessor 102 also makes a request 240 for information on the size ofthe meal that is to be ingested as required by the schedule ofcollection events 222 in order to provide contextual information 156 tothe measurement value.

As mentioned above previously, for each event the software 34 causes theprocessor 102 to assign a unique identifier (e.g. incremental count) 167(FIG. 4) to the data of each request 240 provided in the schedule ofcollection events 222 which meet the adherence criterion 224 in theassociated date record 152 for the collection event 237. Therefore,while the structured collection procedure 70 is being executed, thesoftware 34 permits the user to perform a measurement on the collectiondevice 24 at any time out side the schedule of collection events 222.Such a measurement since not being performed according to a request 240will not be evaluated for the adherence criterion 224, and thus will notbe provided with a unique identifier 167 in the date file but will onlybe provided with a date-time stamp and its measurement value. Such datais still recorded in the data file 145, as such data may still be usefulfor another analysis.

In another embodiment, the software 34 also permits reminders forbiomarker measurements, such as provided in step 368 (FIG. 8C). Forexample, in one embodiment, the processor 102 provides an alarm and/oralert message for a reminder via the indicator 148 and/or on the display108, respectively, to provide a measurement. For example, at the time238 of a particular request 240 for taking a biomarker measurement (orreading), the processor 102 prompts the patient 12 by at leastdisplaying on the display the message, “It is now time for yourreading.” An audible alarm and/or tactile alarm (vibrations) can beprovided by the processor 102 via indicator 148 in another embodiment.For example, in one embodiment, the collection device 24 will providesuch a prompt even when already powered on, such as by the patient 12for another reason, e.g., to conduct a non-scheduled event, when in, forexample, a window of time in which to take the requestedmeasurement/reading, or even when powered downed, such as in a standbymode, by waking up to provide the reminder via the prompt. In anotherembodiment, the provided reminder or prompt can be ‘snoozed’ for apre-defined period as mentioned above, that still falls within thewindow of time in which to take the requested (critical)measurement/reading such as for example, 15 minutes or any other suchsuitable time that falls in the window of time. It is to be appreciatedthat the snooze feature for a measurement/reading that is consideredcritical to the structured collection procedure 70, e.g., ameasurement/reading needed for helping to address the medical use caseor question, needed to meet adherence criteria 224, and/or needed insubsequent analysis for some determination, etc., the snooze featurewill not extend the request 240 beyond the window of time provided bythe structured collection procedure 70 via, e.g., adherence criterion224 for the request 240. For example, in one embodiment one or morecollection events 237 in the schedule of collection events 222 can bepre-defined as critical as well as being a primary sample via use of theoptions parameter 232 (FIG. 7B) provided in the structured collectionprocedure 70. For example, a collection event 237 which is designated ascritical is one that cannot be missed, but if missed can be replaced byanother sample already in the date file 145. A collection event 237which is designated as a primary sample is one that cannot be missed,and which cannot be replaced by another sample, even if available in thedate file 145. In still another embodiment, the snoozing can be up to anumber of times, for non-critical measurements. For example, certaincollection events 237 in the structured collection procedure 70 could bedesignated as having a non-critical request 240, which can be snoozed,such as via selecting such an option that is provided as one of theoptions parameter 232 (FIG. 7B). The options parameter 232 in thisembodiment could for example provide the snooze option as well as aselectable time interval (e.g., 1-60 minutes, etc.) and a selectablenumber of times (e.g., 1-5, etc.) that the user is permitted to snoozethe request 240. In still another embodiment, the collection device 24permits for an alarm shut off i.e., the indicator 148 if providing thereminder (audible, vibratory) can be shut off for the entire window oftime via the user interface 146, but wherein processor 102 still acceptsthe measurement/reading as long as it is made in the window of time.

In still another embodiment, the collection device 24 provides a skipreading option also received by the processor 102 via a selectionentered using the user interface 146, e.g., from a list of selectableoptions, such as for example, snooze, alarm shut off, skip reading,provided on the display 108, in which again no reminder/prompt will beprovided as patient 12 has indicated to the processor 102 that he/shedoes not want to take that particular requested measurement/reading. Itis to be appreciated that selecting the skip reading selection optioncan result in an adherence event 242 resulting in further processing,such as discussed previously above in early sections, if adherencecriterion 224 had been associated with the collection event 237prompting the request 240.

In still another embodiment, the adherence criteria 224 can requirebiomarker measurements to be performed close enough in time to a dataevent request 240. Therefore, if such biomarker measurements areperformed within the period specified by the adherence criteria 224, theprocessor 102 can indicate that the measurements or data entry for theevent is acceptable and tags (i.e., assigns the unique identifier 167)the value of the biomarker measurement or data entry in the data file145 accordingly. In the case of biomarker measurements, if themeasurement is accepted as valid for the data event request 240 (i.e.,meets the adherence criterion(s) 224), the schedule of collection events222 may causes the processor 102 to prompt the user to input additionalinformation if needed by the structured collection procedure 70, such asmentioned above regarding step 370 to provide contextual information 156(i.e., context) to the measurement received in response to a request240.

Such contextual information 156 when inputted via the user interface 146can be stored by the processor 102 in the data file 145 associated withthe unique identifier 167 for the data event request 240 requiring theadditional information. Biomarker measurements determined by theprocessor 102 as not being close enough in time to the data eventrequest 240 as defined by the adherence criteria 224 will not be taggedin the data file 145 by the processor 102. Such is illustrated in theshown data file 145 (FIG. 4) with data event request 240 d and datavalues 256 d not being associated with a unique identifier 167. Anexample of a definition of ‘close enough in time to the collectionprocedure’ as instructed by the adherence criteria 224 to cause theprocessor 102 to make such a determination may be defined as beingrelative to a prescheduled time or a snoozed time. For example, forpre-prandial measurements up to 15 minutes in anticipation isacceptable; for post-prandial measurements, up to 10 minutes inanticipation is acceptable; and for bedtime measurements, up to 15minutes in anticipation is acceptable. Other definitions may be providedin other adherence criteria 224 for other events in the schedule ofcollection events 222 as well as in other structured collectionprocedure.

In the illustrated embodiment, the user uses the buttons 147, 149 toscroll to a selection, which is entered by the processor in the datarecord 152 for the associated request 240 via pressing Okay button 151in step 372. In one embodiment, the meal size can be indicated via anumber range, such as for example, from 1 to 5, where 1 is small and 5is large. In the illustrated embodiment, additional input for contextualinformation 156 regarding a rating of energy level from 1 to 5, where 1is low and 5 is high is requested in step 374, which is entered in thedata file 145 as mentioned previously above via the processor 102receiving input for the request 240 by using the user interface 146 instep 376. In other embodiment, other contextual information 156 mayinclude indicating whether the patient exercised and/or how long. Forexample, the user interface 146 may be use in which yes or 1 to meanover 30 minutes, and no or 2 to mean less than 30 minutes. In theillustrated embodiment, as the exit criterion 228 is now meet viasuccessfully performing steps 368-376, the structured collectionprocedure 70 ends in step 378, wherein the processor 102 again displaysthe list 329, such that the patient 12 may perform other tasks on thecollection device 24, if so desired. Reference is now made to FIG. 9hereafter to discuss the selective display method according to anembodiment of the present invention. It is to be appreciated that one ormore of the method steps discussed hereafter can be provided as computerinstructions stored on a computer readable medium that, when executed bya computer, cause the computer to perform one or more of the methods.

METHOD EXAMPLE

With reference to FIG. 9, in the illustrated method 400, a portablecollection device 24 (FIG. 3) is provided in step 402 which comprises adisplay 108, a user interface 146, a measurement engine 138 to measure abiomarker value, and memory 110 containing the data file 145 and astructured collection procedure 70 (FIG. 7B). The structured collectionprocedure 70 has parameters defining one or more collection events 222,timing 238 for the collection events, and a view flag parameter 239associated with each of the collection events. The view flag parameter239 has a viewable value and a non-viewable value, and each collectionevent 237 comprises one or more requests 240 for a measurement of thebiomarker value and/or information. The collection device 24 furthercomprises a processor 102 connected to the display 108, the userinterface 146, the measurement engine 138, and the memory 110 as well aspower supply 150 for powering the collection device 24. Software 34 isalso provided on the collection device 24 which has instructions thatwhen executed by the processor 102 causes the processor to perform thefollowing processing steps. In step 404, the processor 102 reads thestructured collection procedure 70 from memory 110, and runs thestructured collection procedure in step 406. In step 408, the processor102 sends the requests 240 to the display 108 for the measurement of thebiomarker value and/or for the information according to the timing 238of each of the collection events 237 prescribed in the structuredcollection procedure 70. In step 410, the processor 102 stores eachbiomarker value measured by the measurement engine 138 or informationentered via the user interface 146 in an associated data record 152 inthe data file 145 (FIG. 4) in response to a sent request 240, stores andlinks automatically contextual information associated with eachbiomarker value or the information entered in the associated data record152 of the data file 145 to form contextualized biomarker data, anddesignates the associated data record 152 containing the contextualizedbiomarker data as viewable if the view flag parameter 239 (FIG. 7B)provided for the associated collection event 237 has the viewable value(e.g., Yes) or as not viewable if the view flag has the non-viewablevalue (e.g., No or <null>) in step 412. In one embodiment, the defaultcondition is not viewable wherein the processor 102 makes the datarecord 152 containing the contextualized biomarker data viewable asprescribed in the structured collection procedure 70 for each collectionevent 237 or vice versa in another embodiment. Finally, in step 414, theprocessor 102 provides to the display 108 only those data records 152containing the contextualized biomarker data designated in the memory110 as viewable. In another embodiment, the processor 102 will onlyprovide to the display 108 the biomarker value measured by themeasurement engine 138 per the sent request 240 if the view flagparameter 239 provided in the associated collection event 237 has theviewable value (e.g., Yes).

By the above disclosure, various embodiments of the present inventionhave been presented. For example, in one embodiment, the portablecollection device is a blood glucose meter. In another embodiment, thestructured collection procedure 70 is provided predefined in memory 110of the collection device 24. In another embodiment, the portablecollection device 24 further comprises a communication module 124,wherein the structured collection procedure 70 is programmed externallyand received by the processor 102 from an external device 132 (e.g.,devices 18, 25, or 52) via the communications module and stored intomemory 110 by the processor 102. In still another embodiment, thestructured collection procedure 70 is received via I/R communicationsbetween the processor 102 and the external device 132. In still anotherembodiment, the structured collection procedure 70 is stored into memory110 of the collection device 24 via network-based communications betweenthe processor 102 and the external device 132. In still anotherembodiment, the network-based communications is one of wireless andwired communications. In still another embodiment, the collection device24 further comprises an interface connector 116, wherein the processor102 receives the structured collection procedure 70 via a removablestorage unit 120 connected to the interface connector 116, and in whichthe removable storage unit 120 contains the structured collectionprocedure 70. In still another embodiment, the processor 102 downloadsthe structured collection procedure 70 from the external device 132.

In still another embodiment, the structured collection procedure 70programmatically spans multiple days. In still another embodiment, theportable collection device 24 contains in memory 110 various structuredcollection procedures 70 each having a different use case parameter 220(FIG. 5B), which can be recorded in the data file 145 in an associateduse case field 158 (FIG. 3) to associate such use case with thegenerated data records 152 (FIG. 4). In one embodiment, one of thevarious structured collection procedures 70 is selected through the userinterface 146 for execution by the processor 102. In another embodiment,one of the various structured collection procedures 70 is selectedremotely by an authorized device 134 for execution by the processor 102.In still another embodiment, the any biomarker value measured by themeasurement engine 138 not in response to a sent request 240 of thestructured collection procedure 70 is viewable on the display 108.

In still another embodiment, the user interface 146 and the display 108are provided as a touch screen. In still another embodiment, the userinterface 146 comprises user-operated buttons 147, 149. In still anotherembodiment, the processor 102 implements the structured collectionprocedure 70 when invoked by input received via the user interface 146.

In still another embodiment, the collection device 24 further comprisesa communication module 124, and the processor 102 implements thestructured collection procedure 70 when invoke by input received fromthe communication module 124 from a remote device 132 havingauthorization to invoke the structured collection procedure 70. In stillanother embodiment, the request 240 comprises an indication of mealsize, an indication of energy level, an indication of performingexercise, and combinations thereof.

In still another embodiment, the timing 238 indicates at least one of aspecific date (mm-dd-yyyy), a specific time of day (nn:mm), and anamount of time (n) after a previous collection event 237. In stillanother embodiment, the collection events 222 are at least one of beforebreakfast, after breakfast, before lunch, after lunch, before dinner,after dinner, before bed, before exercising, after exercising, beforereceiving a drug, after receiving a drug, and combination thereof.

In still another embodiment, the processor 102 designates automaticallythe associated data record 152 containing the contextualized biomarkerdata as viewable if the view flag 239 provided in the structuredcollection procedure 70 for the collection event 237 has the viewablevalue by writing a flag (e.g., a binary value, a hex value, an alphanumeric symbol, etc.) to an associated flag field 159 (FIG. 4) in thedata record 152 and as not viewable if the view flag has thenon-viewable value by not writing the flag to the field in theassociated data record. It is to be appreciated that in the embodimentswhere the view flag 239 is set to be conditional viewable, e.g., eitherparameter “AC” or “nAC” provided in the collection procedure 70 (FIG.7B), the associated flag field 159 of the data file 145 will reflect theresults of the checking automatically performed by the processor 102 tosee if the associated adherence criteria 224 is satisfied or not as thecase maybe. For example, if the adherence criteria 224 is not satisfiedin the case of the associated collection event 237 having an “AC”designated view flag 239, then the associated data record 152 containingthe contextualized biomarker data will reflect that the record is notviewable, i.e., not viewable flag “N” recorded by the processor 102automatically in the associated flag field 159. On the other hand, ifthe adherence criteria 224 is satisfied in the case of the associatedcollection event 237 having an “AC” designated view flag 239, then theassociated data record 152 containing the contextualized biomarker datawill reflect that the record is viewable, i.e., viewable flag “Y”recorded by the processor 102 automatically in the associated flag field159 Likewise, the opposite conditions are provided for by the “nAC” viewflag 239, where if the adherence criteria 224 is not satisfied, then theprocessor 102 automatically makes the associated data record 152containing the contextualized biomarker data viewable, i.e., viewableflag “Y”, and on the other hand, not viewable, i.e., not viewable flag“N” recorded in the associated flag field 159, if the adherence criteria224 is satisfied.

In still another embodiment, the software causes the processor 102 topermit an authorized user to select at least one (viewable) criterionunder which a data record 152 of the data file 145 for the structuredcollection procedure 70 is designated as viewable. For example, in oneembodiment, the viewable criterion selected for the biomarker values,that are collected according to the events 237, can be a thresholdvalue, value(s) above and/or below a range, or values that fall within arange. In another embodiment, the viewable criterion can be selectedfrom the contextualized data of such biomarker values, e.g., all morningbiomarker values are viewable, all lunch biomarker values are viewable,all dinner biomarker values are viewable, all bedtime biomarker valuesare viewable, all pre-prandial biomarker values are viewable, allpost-prandial biomarker values are viewable, and combinations thereof.In such embodiments, the software then causes the processor 102 todesignate automatically the associated data record 152 (of the data file145 in the memory 110) containing the contextualized biomarker data asviewable if either the view flag 239 associated with the sent request237 in the structured collection procedure 70 (when being run) has theviewable value e.g., “Y” or the at least one viewable criterion is metand as not viewable if either the view flag 239 has the non-viewablevalue e.g., “N” or the at least one criterion is not met. In the aboveembodiments, the software causes the processor 102 to provide only thosedata (e.g., biomarker) values 256 associated to data records 152 of thedata record 152 if the data records are designated (i.e., via theassociated flag field 159) as viewable.

In still another embodiment, the data file 145 can be downloaded to aremote computer, e.g., clinician computer 25 having analysis software 29in which to view and analyze all data records 152 contained in the datafile 145.

In one embodiment of present invention, the collection device 24 is ablood glucose meter having a specialized mode of operation that may beinvoked directly through the meter or remotely is disclosed. The glucosemeter enables the assessment of certain aspects of a person's medicalsituation by providing built-in support for the automatic execution of atesting regime or structured collection procedure 70 definingmeasurement and a schedule of collection events 222 and maintaining thevalidity the executed structured collection procedure (protocol) byblinding the person to all or some of the test results.

In another embodiment, the patient 12 operates the collection device 24to place the device in a specialized mode of operation which executes a(selected) structured collection procedure 70. In the specialized modeof operation, the collection device 24 interacts with the patient tosupport the execution of the structured collection procedure 70 thatwill enable later the analysis of the targeted medical use casesituation. The structured collection procedure 70 may be preprogrammedin the collection device 24, programmed by a clinician 14 on thecollection device 24 and/or the Clinician computer 25, and downloadeddirectly and/or from a server 52 via a network 50. In the specializedmode of operation, the structured collection procedure 70 allows thepatient to view certain test results but not others. In a particularembodiment, the structured collection procedure 70 contains informationabout which of the test results may be viewed by the patient and whichmay not. This information may be solely protocol related but in anotherembodiment may also take into consideration the usual testing habits ofthe patient.

It is to be appreciated that embodiments of the present inventionenhance existing software and/or hardware that acquires and processesblood glucose (bG) data. The embodiments of the invention can bedirectly incorporated into existing home glucose monitors, or used forthe enhancement of software that retrieves and processes bG data, byintroducing a method for monitoring a patient according to a desiredstructured collection procedure while preventing the patient frommodifying his or her behavior based on collection results. The inventionfurther relates to a computer program and product for implementing theabove-mentioned method.

Having described the disclosure in detail and by reference to specificembodiments thereof, it will be apparent that modifications andvariations are possible without departing from the scope of thedisclosure defined in the appended claims. More specifically, althoughsome aspects of the present disclosure are identified herein aspreferred or particularly advantageous, it is contemplated that thepresent disclosure is not necessarily limited to these preferred aspectsof the disclosure.

1. A portable collection device comprising: a display; a user interface;a measurement engine to measure a biomarker value; memory containing adata file and a structured collection procedure, the structuredcollection procedure having parameters defining: a schedule ofcollection events having one or more collection events which provide arequest for a measurement of the biomarker value under definedconditions which are related to the biomarker value as contextualinformation associated with the biomarker value, and a view flagassociated with each of the one or more collection events, the view flaghaving a viewable value and a non-viewable value; a processor connectedto the display, the user interface, the measurement engine, and thememory; a power supply for powering the device; and software havinginstructions that when executed by the processor causes the processorto: read the structured collection procedure from memory, permit anauthorized user to select at least one criterion under which a datarecord of the data file for the structured collection procedure isdesignated as viewable, run the structured collection procedure, sendautomatically the request of each of the one or more collection eventsaccording to the structured collection procedure, store automaticallybiomarker value(s) measured by the measurement engine or informationentered via the user interface in an associated data record of the datafile in the memory in response to sent request, store and linkautomatically contextual information associated with each biomarkervalue or the information entered in the associated data record of thedata file to form contextualized biomarker data, designate automaticallythe associated data record in the memory containing the contextualizedbiomarker data as viewable if the view flag associated with the sentrequest in the structured collection procedure has the viewable value orthe at least one criterion is met and as not viewable if the view flaghas the non-viewable value or the at least one criterion is not met, andprovide to the display only biomarker values associated to data recordscontaining the contextualized biomarker data if the data records aredesignated in the memory as viewable.
 2. The portable collection deviceaccording to claim 1, wherein the structured collection procedurefurther comprises entry criterion defining one or more conditions whichwhen satisfied start the schedule of collection events, and exitcriterion defining one or more conditions which when satisfied end thestructured collection procedure, and wherein the software havinginstructions that when executed by the processor further causes theprocessor to run automatically the structured collection procedure whenthe entry criterion is satisfied, and end automatically the structuredcollection procedure when the exit criterion is satisfied.
 3. Theportable collection device according to claim 1, wherein the at leastone viewable criterion is at least one of a threshold value for thebiomarker value, value(s) above and/or below a range, and values thatfall within a range.
 4. The portable collection device according toclaim 1, wherein the at least one viewable criterion is selected fromthe contextualized data of the biomarker value.
 5. The portablecollection device according to claim 1, wherein the portable collectiondevice is a portable device selected from a blood glucose meter and acontinuous glucose monitor.
 6. The portable collection device accordingto claim 1, wherein the structured collection procedure is predefined inthe collection device.
 7. The portable collection device according toclaim 1, wherein the portable collection device further comprises acommunications module, wherein the structured collection procedure isprogrammed externally and the processor receives the structuredcollection procedure from an external device via the communicationsmodule.
 8. The portable collection device according to claim 5, whereinthe structured collection procedure is received via I/R communicationsbetween the processor and the external device.
 9. The portablecollection device according to claim 5, wherein the structuredcollection procedure is received via network based communicationsbetween the processor and the external device.
 10. The portablecollection device according to claim 7, wherein the network basedcommunications is one of wireless and wired communications.
 11. Theportable collection device according to claim 1, wherein the portablecollection device further comprises an interface connector, and whereinthe processor receives the structured collection procedure via aremovable storage device connected to the interface connector, theremovable storage device containing the structured collection procedure.12. The portable collection device according to claim 1, wherein theprocessor downloads the structured collection procedure from an externaldevice.
 13. The portable collection device according to claim 1, whereinthe structured collection procedure spans multiple days.
 14. Theportable collection device according to claim 1, wherein the portablecollection device contains in memory various structured collectionprocedures each defining a different structured collection procedure,and wherein one of the various structured collection procedures isselected through the user interface for execution by the processor. 15.The portable collection device according to claim 1, wherein the devicecontains in memory various structured collection procedures eachdefining a different structured collection procedure, and wherein one ofthe various structured collection procedures is selected remotely by anauthorized device for execution by the processor.
 16. The portablecollection device according to claim 1, wherein any biomarker valuemeasured by the measurement engine not in response to a sent request isviewable on the display.
 17. The portable collection device according toclaim 1, wherein any biomarker value measured by the measurement enginewhich indicates a hypoglycemic or hyperglycemic condition is viewable onthe display.
 18. The portable collection device according to claim 1,wherein the user interface and the display are provided together as atouchscreen.
 19. The portable collection device according to claim 1,wherein the user interface comprises user-operated buttons.
 20. Theportable collection device according to claim 1, wherein the processorimplements the structured collection procedure when invoked throughinput received from the user interface.
 21. The portable collectiondevice according to claim 1, wherein the device further comprises acommunication device, and the processor implements the structuredcollection procedure when invoked by input received from thecommunication device from a remote device having authorization to invokethe structured collection procedure.
 22. The portable collection deviceaccording to claim 1, wherein the collection event further comprises arequest for an indication of meal size, a request for an indication ofenergy level, a request for an indication of completion of prescribedexercise, and combinations thereof.
 23. The portable collection deviceaccording to claim 1, wherein the timing indicates at least one of aspecific date, a specific time of day, and an amount of time after aprevious collection event.
 24. The portable collection device accordingto claim 1, wherein the collection events are at least one of beforebreakfast, after breakfast, before lunch, after lunch, before dinner,after dinner, before bed, before exercising, after exercising, beforereceiving a drug, after receiving a drug, and combinations thereof. 25.The portable collection device according to claim 1, wherein theprocessor designates the contextualized biomarker data in the associateddata record as viewable if the view flag provided in the structuredcollection procedure for the collection event has the viewable value bywriting a flag to a field in the associated data record and as notviewable if the view flag has the non-viewable value by not writing theflag to the field in the associated data record.
 26. The portablecollection device according to claim 1, wherein the data file isdownloaded to a remote computer having analysis software in which toview and analyze all data records contained in the data file.
 27. Theportable collection device according to claim 1, wherein the structuredcollection procedure further has a parameter defining one or moreadherence criteria, and the view flag of the structured collectionprocedure further has a conditionally viewable value, and wherein thesoftware has instructions that when executed by the processor causes theprocessor to use the one or more adherence criteria as a logical switchto decide whether the associated data record in the memory is viewablewhen the view flag associated with the sent request in the structuredcollection procedure has the conditionally viewable value.
 28. Theportable collection device according to claim 25, wherein the processorautomatically designates the contextualized biomarker data in theassociated data record in the memory as viewable when the view flagassociated with the sent request in the structured collection procedurehas the conditionally viewable value and the one or more adherencecriteria is satisfied by the biomarker value measured by the measurementengine or the information entered via the user interface in response tothe sent request.
 29. The portable collection device according to claim25, wherein the processor automatically designates the contextualizedbiomarker data in the associated data record in the memory as viewablewhen the view flag associated with the sent request in the structuredcollection procedure has the conditionally viewable value and the one ormore adherence criteria is not satisfied by the biomarker value measuredby the measurement engine or the information entered via the userinterface in response to the sent request.
 30. The portable collectiondevice according to claim 25, wherein the structured collectionprocedure further has a parameter defining one or more options, andwherein the software has instructions that when executed by theprocessor further causes the processor to send a message when the one ormore adherence criteria is satisfied by the biomarker value measured bythe measurement engine or the information entered via the user interfacein response to the sent request.
 31. The portable collection deviceaccording to claim 25, wherein the structured collection procedurefurther has a parameter defining one or more options, and wherein thesoftware has instructions that when executed by the processor furthercauses the processor to send a message when the one or more adherencecriteria is not satisfied by the biomarker value measured by themeasurement engine or the information entered via the user interface inresponse to the sent request.
 32. The portable collection deviceaccording to claim 1, wherein the software has further instructions thatwhen executed by the processor causes the processor to permit anauthorized user to select which of the one or more collection events isassigned the viewable value or the non-viewable value of the view flag.33. A method for monitoring a patient according to a desired structuredcollection procedure while preventing the patient from modifying his orher behavior based on collection results, said method comprising:providing a portable collection device according to claim 1; and runningthe software provided on the collection device such that the processor:reads the structured collection procedure from memory, runs thestructured collection procedure, sends automatically requests to thedisplay according to the timing of the collection events prescribed bythe structured collection procedure, stores automatically each biomarkervalue measured by the measurement engine or information entered via theuser interface in an associated data record of the data file in thememory in response to the sent requests, stores and links automaticallycontextual information associated with each biomarker value or theinformation entered in the associated data record of the data file toform contextualized biomarker data, designates automatically theassociated data record containing the contextualized biomarker data inthe memory as viewable if the view flag provided in the structuredcollection procedure for the collection event has the viewable value andas not viewable if the view flag has the non-viewable value, andprovides to the display only data records containing the contextualizedbiomarker data designated in the memory as viewable.
 34. The methodaccording to claim 33, further comprising permitting the authorized userto select the at least one criterion under which the data record of thedata file for the structured collection procedure is designated asviewable.
 35. The method according to claim 33, further comprisingpermitting the authorized user to select in the structured collectionprocedure for the collection event either the viewable value or thenon-viewable value of the view flag.
 36. A computer readable storagemedium storing software comprising instructions that when executed by acollection device having a processor, a measurement engine for measuringa biomarker value, a user interface, memory, and a display performs amethod for monitoring a patient according to a desired structuredcollection procedure while preventing the patient from modifying his orher behavior based on collection results, comprising: running thestructured collection procedure; sending automatically requests to theuser interface according to timing of collection events prescribed bythe structured collection procedure; storing automatically eachbiomarker value measured by the measurement engine or informationentered via the user interface in an associated data record in a datafile provided in the memory in response to the sent requests; storingand linking automatically contextual information associated with eachbiomarker value or the information entered in the associated data recordof the data file to form contextualized biomarker data; designatingautomatically the associated data record in the memory as viewable ifthe view flag provided in the structured collection procedure for thecollection event has the viewable value and as not viewable if the viewflag has the non-viewable value; and providing to the display only datarecords containing the contextualized biomarker data designated in thememory as viewable.